Medical device recalls for June 2013

Class I recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

Medtronic Xomed; Inc. Jun-04-2013 NIM TriVantage EMG Endotracheal Tube – REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed; Inc.; 6743 Southpoint Drive North; Jacksonville; FL 32216-0980 USA STERILE Rx OnlyThe electrodes are designed to make contact with the patient’s vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to a multi-channel EMG neuromonitoring device. In March 2013; Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the continued ventilation of the patient.

Symbios Medical Products; LLC Jun-06-2013 GOBlock – Part 510613 Disposable Infusion Pump; …Elastomeric Pump 300mL (150 mL side)( 6mL/hr );… found in the following kitsGoBlock Kit 510612;Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable; self contained infusion system. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOBlock – Part 510636 Disposable Infusion Pump; …Elastomeric Pump 600 mL( 300 ml perside); 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits:GoBlock Kit 510646;Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable; self contained infusion system. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part 510449 Disposable Infusion Pump; …Elastomeric Pump 600 mL( 8mL/hr );… found in the following kitsGoBlock Kit 510472;Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part 510121 Disposable Infusion Pump; …Elastomeric Pump 300 mL; 4mL/hr;…sterile.. found in the following kitsGoPump Kit 510203-BP; Epidural catheter & BIOPATCHGoPump Kit 510204; 2.5" Fenestrated catheterGoPump Kit 510204 BP; 2.5 Fenestrated catheter & BiopatchGoPump Kit 510205BP; 5" Fenestrated catheter & BiopatchGoPump Kit 510551-BP; 2.5 Fenestrated catheter & BiopatchGoBlock kit 510608Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part 510180 Disposable Single Infusion Pump; … Elastomeric Pump 300 mL; 2mL/hr;… found in : GoPump Kit 510201-BP; 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP; Epidural Catheter; BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part 510076 Disposable Dual Infusion Pump; …Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side;… Sterile; found in the following kits: GoPump kit 510080-BP; 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP; 2.5" fenestrated catheter & BIOPATCHGo Pump Kit 510141-BP;10" fenestrated catheter& BIOPATCHDisposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part 510031 Disposable Single Infusion Pump; quantity Includes… TOTAL VOLUME: 150mL; 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacitySterile EO… found in the following GoPump Kits: GoPump Kit 510042; w/ Epidural CatheterGoPump Kit 510042 – BP; w/ Epidural Catheter; BIOPATCHGoPump Kit 510110; w/2.5" Fenestrated Catheter GoPumpKit 510110-BP; w/2.5" Fenestrated Catheter;BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter; BIOPATCHGoPumpKit 510556-BP ; 2.5 catheter; BIOPATCHSymbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOBlock – Part 510490 Disposable Infusion Pump; …Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr );… found in the following kitsGoBlock Kit 510491;Disposable Single Infusion Pump for drug delivery Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOBlock – Part 510450 Disposable Infusion Pump; …Elastomeric Pump 600 mL( 10mL/hr );… found in the following kitsGoBlock Kit 510458;Disposable Single Infusion Pump Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Symbios Medical Products; LLC Jun-06-2013 GOPump – Part510447 Disposable Infusion Pump; …Elastomeric Pump 600 mL; 2mL/hr/side;… found in the following kitsGoPump Kit 510462-BP; 5 " catheter & BIOPATCHGoPump Kit 510558-BP 10 " catheter& BIOPATCHGoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Symbios Medical Products; Indianapolis; Indiana; is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir; 2 mL/hr GOPump (PN510031); and the

Endologix Inc Jun-07-2013 Catheter; Introducer – Brand Name: AFX" Introducer System; Model Number S17-45.Lot Numbers: 1079840; 1079843; 1079844; 1079845.Product Usage:The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction. Endologix; Inc. initiated this voluntary recall of certain lots of Endologix; Inc. due to reports of dilator breakage during clinical procedures.

Respironics California Inc Jun-17-2013 V60 Ventilator – Respironics V60 Ventilator; Model #V60Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008)1053613 (989805628251)1053614 (989805612101)1053615 (989805613391)1053616 (989805613661)1053617 (989805611761)1053618 (n/a)R1053618 (n/a)1076709 (n/a)1076715 (989805627411)1076716 (989805627431)1076717 (989805627441)DU1053617 (989805616411)U1053614 (989805636441)U1053617 (989805636631)Power Mgmt. Board; Respironics Material P/N: 1054358; Philips 12 Digit P/N: 4536561512581.The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure; respiratory insufficiency; or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 lbs.) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals; such as physicians; nurses; and respiratory therapists. Respironics California; Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly; it may cause ventilator support to be lost with potentially no audible alarm from the ventilator.

Verathon; Inc. Jun-20-2013 The GlideScope Video Laryngoscope GVL 3; 4; 5 and AVL 2; 3; 4 and 5 – GlideScope Video Laryngoscope (GVL) 3; 4; 5 and GlideScope (AVL) 2; 3; 4 and 5 reusable bladesProduct Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear; unobstructed view of the vocal cords for medical procedures. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform. Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.

Medtronic Neuromodulation Jun-24-2013 Medtronic Intrathecal Catheter – Medtronic Intrathecal Catheter; model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire; 66-cm pump segment; 15 T-gauge introducer needle; Transparent Strain-relief sleeves; Opaque Strain-relief sleeves; and V-wing anchors. Contents of inner package are STERILE.The implantable Medtronic Model 8731SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731SC catheter. The catheter connects to the pump at the catheter port. The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design; and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Medtronic Neuromodulation Jun-24-2013 Medtronic INDURA 1P Intrathecal Catheter – Medtronic INDURA 1P Intrathecal Catheter; model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire; 15 T-gauge introducer needle; Sutureless pump connector with attached 7.6-cm catheter and Connector pin; Transparent Strain-relief sleeves; and anchors. Contents of inner package are STERILE.The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port. The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design; and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Medtronic Neuromodulation Jun-24-2013 Medtronic Intrathecal Catheter Pump Segment Revision Kit – Medtronic Intrathecal Catheter Pump Segment Revision Kit; model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector; Spinal Segment Strain-relief sleeves; Pump segment strain-relief sleeves; Connector pin. Contents of inner package are STERILE.The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port. The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design; and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Medtronic Neuromodulation Jun-24-2013 Medtronic Sutureless Pump Connector Revision Kit – Medtronic Sutureless Pump Connector Revision Kit; model 8578. Contents: catheter interface with attached sutureless pump connector; catheter; connector pin; and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE.The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port. The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design; and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.

Medtronic Neuromodulation Jun-25-2013 SynchroMed EL Implantable Infusion Pump – Medtronic SynchroMed EL Programmable pumps; Models 8626; 8626L; 8627; 8627L; (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription; the drug moves from the pump reservoir; through the pump tubing; catheter port; and catheter; to the infusion site.The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal to they SynchroMed infusion pump. An electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of und

Medtronic Neuromodulation Jun-25-2013 SynchroMed II Implantable Infusion Pump – Medtronic SynchroMed II; Model 8637; (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump; catheter; and catheter accessories.The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain; Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain; Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity; Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.

Medtronic Neuromodulation Jun-25-2013 SynchroMed II Implantable Infusion Pump – Medtronic SynchroMed EL Programmable pumps; Models 8626; 8626L; 8627; 8627L; (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage:The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The drug is stored in the pump reservoir. Per a programmed prescription; the drug moves from the pump reservoir; through the pump tubing; catheter port; and catheter; to the infusion site. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain; Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain; Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity; Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.

Class II recalls

Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall

I-Flow LLC Jun-03-2013 I-Flow ON-Q Pain Relief System – I-Flow ON-Q Pain Relief System; T-Block Needle/Catheter Kit; Model #TB089TThe intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission. I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

Leica Microsystems; Inc. Jun-03-2013 LPC Fine Mesh Cassettes – LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing. An LPC Fine Mesh Cassette failed to stay closed during processing operations.

I-Flow LLC Jun-03-2013 I-Flow ON-Q Pain Relief System – I-Flow ON-Q Pain Relief System; T-Block Needle/Catheter Tray; Model #TBTB1089TThe intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission. I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

GE Healthcare; LLC Jun-03-2013 Aespire; Aespire View; Avance; Avance CS2; Aisys; ADU; 9100; M900; M904; 9300 systems – Canister: CO2 canister with GE part numbers 1407-3200-000; 1407-7004-000; or M1084850. Intended to provide general inhalation anesthesia and ventilatory support. GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire; Aespire View; Avance; Avance CS2; Aisys; ADU; 9100; M900; M904; 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.

Shimadzu Medical Systems Jun-03-2013 Mobile DaRt Evolution – Shimadzu Corporation – Mobile DaRt EvolutionThis device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency . The recall was initiated because Shimadzu Corporation has identified a potential issue in certain manufacturing lots of the Shimadzu MobileDaRt Evolution in combination with CXDI-70C; CXDI-55C; and CXDI-55G. As a result of Shimadzu’s investigation; there is a potential risk for screws becoming loose inside the Shimadzu Mobile X-ray systems.

Maytex Corp Jun-04-2013 Comfort Ear-Loop Face Mask – Comfort brand Ear-Loop Face Mask; Item #: 3100; Model Numbers: # 3100B; # 3100P; # 3100G; # 3100Y; # 3100W; Product is manufactured and distributed by Maytex Corporation; CAEar-loop face mask for basic medical/dental procedures. Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 – 2012 cannot be guaranteed as Fluid Resistant.

Intuitive Surgical; Inc. Jun-05-2013 da Vinci 5 mm Instrument Cannulae – da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.Used to establish a port of entry for Intuitive Surgical EndoWrist instruments; Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Intuitive Surgical; Inc. Jun-05-2013 da Vinci 5 mm Flared Instrument Cannulae – da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.Used to establish a port of entry for Intuitive Surgical EndoWrist instruments Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

SpineFrontier; Inc. Jun-05-2013 Dorado Straight Impactor – Straight Impactor – Dorado IBC; Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

Coloplast Manufacturing US; LLC Jun-05-2013 Digitex 2-0 Polydioxanone (PDO) suture – Digitex Absorbable Polydiaxanone Suture; Size 2-0. Catalog Number / Code of product: 52031; 5203101400.The Digitex Delivery Device is a sterile; disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture; and suture ligation and know-typing by holding the suture. Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture; Size 2-0 because it is mislabeled with a three year expiration date.

Kreg Medical Inc. Jun-05-2013 EZ Wider Bariatric Bed – E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use; leaving the patient in a forward tilt position.

Covidien LP Jun-05-2013 Versaport Bladeless Optical Fixation Cannula – 5mm Short – Versaport Bladeless Optical Fixation Cannula – 5mm ShortProduct Code: ONBFCA5SHThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP Jun-05-2013 Versaport Bladeless Optical Fixation Cannula – 5mm – Versaport Bladeless Optical Fixation Cannula – 5mmProduct Code: ONBFCA5STThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP Jun-05-2013 Versaport Bladeless Optical Trocar With (2) Fixation Cannulae – 5mm – Versaport Bladeless Optical Trocar With (2) Fixation Cannulae – 5mmProduct Code: ONB5STF2CThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP Jun-05-2013 Versaport Bladeless Optical Trocar With Fixation Cannula – 5mm – Versaport Bladeless Optical Trocar With Fixation Cannula – 5mmProduct Code: ONB5STFThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Covidien LP Jun-05-2013 Versaport Bladeless Optical Trocar With Fixation Cannula – 5mm Short – Versaport Bladeless Optical Trocar With Fixation Cannula – 5mm ShortProduct Code: ONB5SHFThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Biomet; Inc. Jun-05-2013 E1 Advantage Head – Active Articulation E1.Intended for use with either primary or revision hip arthroplasty. Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size.The implant itself is etched with the correct O.D. size.

Covidien LP Jun-05-2013 Versaport Bladeless Optical Trocar With Fixation Cannula – 5mm Long – Versaport Bladeless Optical Trocar With Fixation Cannula – 5mm Long Product Code: ONB5LGFThe Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic; general; thoracic and urologic endoscopic procedures to create and maintain a port of entry. Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Philips Medical Systems (Cleveland) Inc Jun-05-2013 BrightView SPECT gamma camera for Emission Computed Tomography – BrightView SPECT gamma camera for Emission Computed Tomography; Philips Medical Systems; Cleveland; OH 44143BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies. Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.

Zimmer Surgical Inc Jun-05-2013 Air Dermatome II – Zimmer Air Dermatome II; REF 00-8851-001-01handpiece; w/o hose; Rx; non-sterilegrafting instruments intended to provide variable graft thickness and width capabilities. This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate oroperate intermittently. Zimmer’s investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

Zimmer Surgical Inc Jun-05-2013 Air Dermatome II – Zimmer Air Dermatome II; REF 00-8851-001-00handpieceRx; non-sterilegrafting instruments intended to provide variable graft thickness and width capabilities This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer’s investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

Zimmer Surgical Inc Jun-05-2013 Air Dermatome – The Zimmer Air Dermatome; REF 00- 8801- 001- 00 ;Rx; non-sterilegrafting instruments intended to provide variable graft thickness and width capabilities This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer’s investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

Hill-Rom; Inc. Jun-05-2013 Hill-Rom 1000 Bed – Hill-Rom 1000 Bed; Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital. Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame.

Hill-Rom; Inc. Jun-05-2013 SlingBar Standard – SlingBar Standard.Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient; caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury; Hill-Romis requesting products be removed from field use andreplaced with an updated design.

Hill-Rom; Inc. Jun-05-2013 SlingBar 670 – SlingBar Wide 670. Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient; caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury; Hill-Romis requesting products be removed from field use andreplaced with an updated design.

Hill-Rom; Inc. Jun-05-2013 SlingBar 350 – SlingBar 350.Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient; caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury; Hill-Romis requesting products be removed from field use andreplaced with an updated design.

Hill-Rom; Inc. Jun-05-2013 SlingBar 360 – SlingBar 360.Designed to meet the needs for lifting humans. Retrospective review found 4 sling bars that may present a potential for impalement if a patient; caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury; Hill-Romis requesting products be removed from field use andreplaced with an updated design.

Siemens Healthcare Diagnostics; Inc Jun-06-2013 Siemens ADVIA Centaur iPTH Calibrator – ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394.For in vitro diagnostic use in calibrating Intact PTH assays. iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Siemens Healthcare Diagnostics; Inc Jun-06-2013 Siemens ADVIA Centaur¿ iPTH ReadyPack Assay – ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368.For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Siemens Healthcare Diagnostics; Inc Jun-06-2013 Siemens ADVIA Centaur¿ iPTH ReadyPack Assay – ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369; 10493615; 1049361.For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH). iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Siemens Healthcare Diagnostics; Inc Jun-06-2013 Siemens ADVIA Centaur¿ iPTH Calibrator – ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387; 10630628.For in vitro diagnostic use in calibrating Intact PTH assays. iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Cordis Corporation Jun-06-2013 FLEXSTENT Biliary Self-Expanding Stent System (US Commercial- 80 cm Length) – FLEXSTENT Biliary Self-Expanding Stent System. Product Usage:The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Holes and/or tears can be introduced in the FLEXSTENT? inner pouch under some conditions; and to a lesser degree; in the outer pouch.

Cordis Corporation Jun-06-2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System (Clinical Study Protocol FSS-0003 (OPEN trial) – FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage:The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. Holes and/or tears can be introduced in the FLEXSTENT? inner pouch under some conditions; and to a lesser degree; in the outer pouch.

Cordis Corporation Jun-06-2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System (EU Commercial- 120 cm Length) – FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage:The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. Holes and/or tears can be introduced in the FLEXSTENT? inner pouch under some conditions; and to a lesser degree; in the outer pouch.

Cordis Corporation Jun-06-2013 FLEXSTENT Femoropopliteal Self-Expanding Stent System (EU Commercial- 80 cm Length) – FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage:The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions. Holes and/or tears can be introduced in the FLEXSTENT? inner pouch under some conditions; and to a lesser degree; in the outer pouch.

Cordis Corporation Jun-06-2013 FLEXSTENT Biliary Self-Expanding Stent System (US Commercial- 120 cm Length) – FLEXSTENT Biliary Self-Expanding Stent System. Product Usage:The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree. Holes and/or tears can be introduced in the FLEXSTENT? inner pouch under some conditions; and to a lesser degree; in the outer pouch.

AGFA Corp. Jun-06-2013 DX-D 100 MOBILE DR – AGFA Digital Radiography X-Ray System DX-D 100Agfa’s DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull; spinal column and extremities: chest; abdomen; and other body parts. Customers could potentially experience intermittent; unintended and illogical movement when using the product.

Berchtold Corp. Jun-06-2013 OPERON Hand Controls for Operon D750; D752; D760; D820 and D850 – Hand Controls for Operon D750; D752; D760; D820 and D850The hand controls are used to operate OPERON surgical tables The firm received complaints for unintended movements.

Alcon Grieshaber AG Jun-06-2013 Constellation Vision System Pneumatic Handpiece – The Constellation Vision System Pneumatic Handpiece.Indicated for both anterior and posterior segment opthalmic surgery. Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece; DSP; product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece; if not attached by the user according to the Directions for Use.

American Optisurgical Inc Jun-06-2013 FAST Procedure Kit – FAST Procedure Kit.Intended for use as a Minor Surgical Procedures Tray. American Optisurgical; Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator; in response to a sub-recall letter from Medline Industries; Inc due to lack of sterility assurance caused by an incomplete seal on the individualunit packaging.

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-710-000T4 Pullover Toga (S/M) Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-850-100 T5 zipper Togawith Peel Away; Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-720-000S5 T5 Pullover Togaw/Peel Away; Sterile; EO; single use.Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments0400-750-000 T4 Toga; Pullover; Regular Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-760-000 T4 Toga; Pullover; Large Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-770-000 T4 Toga; Pullover; Ex-Large Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-810-000 T4 Zipper Toga(S/M) Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-820-000 T4 Zipper Toga(L/XL) Sterile; O; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-820-000S3 T4 Toga w/InsideShoulder Ties; Sterile; O; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3Cut; Sterile; O; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-820-100 T5 Zipper Togawith Peel Away; Sterile; O; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-830-000 T4 Toga; Zipper; Regular; Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-840-000 T4 Toga; Zipper; Large; Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-850-000 T4 Toga; Zipper;(XL-Tall) Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation Jun-06-2013 Hytrel Toga – Stryker Instruments 0400-850-000S2 T4 Toga; XL; w/Inside Tie) Sterile; EO; single use; Product Usage:Protection System and are intended to protect the patient; healthcare personnel and operating room personnel against contamination; exposure of infectious bodily fluids; and the transfer of microorganismsand particulate material. Based on an accelerated aging test for this product packaging; there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

American Optisurgical Inc Jun-06-2013 TX1 Tissue Removal System – American Optisurgical’s TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall; American Optisurgical; Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo

Applied Medical Resources Corp Jun-07-2013 Epix¿ and Direct Drive Laparoscopic Graspers – Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers; Model Numbers C4130 and C4140.Used for grasping and manipulating tissue during general or laparoscopic surgery. Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix? and Direct Drive LaparoscopicGraspers. When the ratchet trigger is activated; if a great enough force is applied; there is a potential for the triggerto fracture and the jaws to remain in the closed position. The likelihood of this situation to occur and result inpermanent patient injury is highly unlikely;

American Optisurgical Inc Jun-07-2013 TX1 Tissue Removal System – TX1 Tissue Removal System disposable handpieces.Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation; emulsification and aspiration of soft tissue are desirable; including General Surgery; Orthopedic Surgery; Laparoscopic Surgery and Plastic and Reconstructive Surgery. American Optisurgical; Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.

Dental EZ Stardental Division Jun-07-2013 StarDental Classique(TM) Diamond Dental Bur – StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures. Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.

DePuy Orthopaedics; Inc. Jun-07-2013 Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System – DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.

Invatec Llc Jun-07-2013 lnvatec SpA brand Diver C.E – lnvatec SpA brand Diver C.E.; Model/Catalog Numbers: DVR010014145; DVR011014145; Product is manufactured by lnvatec SpA; Roncadelle; Italy; and distributed by Invatec; Inc.; Bethlehem; PA and by Medtronic Endovascular Therapies; Santa Rosa; CAThe Diver C.E. product is an aspiration catheter indicated for the removal of fresh; soft emboli and thrombi from vessels in the arterial system. Devices labeled for an intended use was not included in the existing 510(k) or PMA; in that; the Indications for use was modified.

Bard Peripheral Vascular Inc Jun-08-2013 UltraClip Dual Trigger breast tissue marker – BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot numbercombination may have the metal tissue marker separated from the needle prior to use.

Fenwal Inc Jun-08-2013 AMICUS Exchange Kit – AMICUS Exchange Kit; Product Usage:This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339; AmicusExchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s

Siemens Healthcare Diagnostics; Inc. Jun-08-2013 MicroScan Dried Negative Breakpoint Combo – Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417); SMN #: 10483099); For use in determining quantitative and/or qualitative antimicrobial agent susceptibility. The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition; 42 hour identification panel holds may occur due to a weak ARG reaction.

Bard Peripheral Vascular Inc Jun-10-2013 BARD Biopsy Systems – BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular; Inc.); UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle; Ultrasound Enhanced Coil Marker 5 Pack; Sterilize; Non-pyrogenic; Rx only; Single Use; Bard Peripheral Vascular; Inc.; 1625 West 3rd Street; Tempe; AZ 85281 USA.PK4320100 Rev. 0 03/10The UltraClip Dual Trigger breast tissue marker is a sterile; single use device comprised of a disposable introducer; and a metal implantable tissue marker with polyvinyl alcohol (PVA). Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard? UltraClip? Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

Bard Peripheral Vascular Inc Jun-10-2013 USHER¿ Support Catheter- Angled Tip WL130cm – USHER¿ Support Catheter- Angled Tip WL130cm; RI 7F; REF USH07AT; PK1022-01A; Rx only; Non-Pyrogenic; Sterile; Bard Peripheral Vascular; Manuf: FlowCardia; Inc.; a Subsidiary of C. R. Bard; Inc.; 745 North Pastoria Ave; Sunnyvale CA 95085. The Usher¿ Peripheral is a single lumen support catheter; with a standard luer fitting at the proximal end. The Usher¿ Peripheral is available in a length 130 cm with an angled tip shape. Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard? UltraClip? Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

Bard Peripheral Vascular Inc Jun-10-2013 MICROSHEATH¿ – 0.066 (1.7mm) proximal; 0.064 (1.6mm); – MICROSHEATH¿ – 0.066 (1.7mm) proximal; 0.064 (1.6mm); WL 123cm; RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal; straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia; Inc.; a Subsidiary of C.R. Bard; Inc. 745 North Pastoria Ave.; Sunnyvale; CA 94085.The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard? UltraClip? Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

Bard Peripheral Vascular Inc Jun-10-2013 BARD Biopsy Systems – BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular; Inc.); UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle; Ultrasound Enhanced Ribbon Marker 5 Pack; Sterile; Single Use; Non-pyrogenic; Rx only; Bard Peripheral Vascular; Inc.; 1625 West 3rd Street; Tempe; AZ 85281 USA. PK4313800 Rev. 1 01/11The UltraClip Dual Trigger breast tissue marker is a sterile; single use device comprised of a disposable introducer; and a metal implantable tissue marker with polyvinyl alcohol (PVA). Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard? UltraClip? Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).

Embla System Llc Jun-11-2013 Embletta Gold – embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).The Embletta Gold is a battery operated device which records physiologic signals used in the diagnosis of sleep disorders. It is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The recorder is not equiped with an alarm device and is not intended to be used as a life monitor. It may be used in a variety of configurations and the recording of physiologic signals of a sleeping patient.Item Numbers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alibration error for Embla Embletta Gold units calibrated through service center between June 15; 2012 to February 27; 2013. This calibration error could cause a clinician to over titrate the patient and prescribe a therapy pressure higher than is necessary.

Ethicon Endo-Surgery Inc Jun-11-2013 ECHELON 60mm Endoscopic Linear Cutter Reloads Black – ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid.The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile; single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples; three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments’¿" lock-out feature is designed to prevent a used reload from being refired. Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.

International Biomedical; Ltd. Jun-11-2013 VIA Medical Collection Bag – VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102). International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture; the connector on the collection bag has been improved to

OrthoPediatrics Corp Jun-12-2013 OrthoPediatrics PediLoc Locking Cannulated Blade Plate System – 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 HoleProduct Usage:The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies; femoral neck and pertrochanteric fractures; intertrochanteric valgus osteotomies; proximal and distal tibial osteotomies and humeral fractures and osteotomies. Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

OrthoPediatrics Corp Jun-12-2013 OrthoPediatrics PediLoc Locking Cannulated Blade Plate System – 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 HoleProduct Usage:The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies; femoral neck and pertrochanteric fractures; intertrochanteric valgus osteotomies; proximal and distal tibial osteotomies and humeral fractures and osteotomies. Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

OrthoPediatrics Corp Jun-12-2013 OrthoPediatrics PediLoc Locking Cannulated Blade Plate System – 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 HoleProduct Usage:The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies; femoral neck and pertrochanteric fractures; intertrochanteric valgus osteotomies; proximal and distal tibial osteotomies and humeral fractures and osteotomies. Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

Bard Peripheral Vascular Inc Jun-12-2013 PTA Balloon Dilatation Catheters – BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters; 8mm x 4cm x 80cm.Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral; iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents; self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied sterile and intended for single use. Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically; the balloon size printed on the hub may read 7mm x 4cm; when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon size.

Edwards Lifesciences; LLC Jun-13-2013 QuickDraw Venous Cannula – QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed; peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton.Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed; peel-type pouch. Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Abbott Medical Optics; Inc. Jun-13-2013 STAR S3 ActiveTrack Excimer System (STAR S3) – STAR S3 ActiveTrack Excimer System (STAR S3)Mfg by AMO Manufacturing USA; LLC510 cottonwood DriveMilpitas; CA 95035The STAR Excimer Laser System; a class Ill device; is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Under specific conditions; there is an unlikely potential to result in inadvertent laser firing of the laser.

Abbott Medical Optics; Inc. Jun-13-2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) – STAR S4 with Variable Spot Scanning Excimer System (STAR S4)Mfg by AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035The STAR Excimer Laser System; a class Ill device; is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Under specific conditions; there is an unlikely potential to result in inadvertent laser firing of the laser.

Abbott Medical Optics; Inc. Jun-13-2013 STAR S4 IR Excimer System (STAR S4 IR) – STAR S4 IR Excimer System (STAR S4 IR)Mfg by AMO Manufacturing USA; LLC510 Cottonwood DriveMilpitas; CA 95035The STAR Excimer Laser System; a class Ill device; is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Under specific conditions; there is an unlikely potential to result in inadvertent laser firing of the laser.

Utah Medical Products; Inc Jun-13-2013 Deltran Kit – Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device; Product Usage: Deltran is a disposable pressure transducer that provides consistent and accurate readings during invasive blood pressure monitoring of humans and animals. Utah Medical Products; Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.

Ormco/Sybronendo Jun-14-2013 SybronEndo Elements Obturation Unit; – SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo; 1332 S. Lone Hill Ave. Glendora; CA 91740; EU Rep: Kerr Italia; S.r.l; Via Passanti; 332; 1-84018 Scafati (SA); ItalyThe intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus; for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

Ormco/Sybronendo Jun-14-2013 SybronEndo Replacement AC Power Cord; US Elements Obturation; – SybronEndo Replacement AC Power Cord; US Elements Obturation; REF 973-0334; SybronEndo; 1332 S. Lone Hill Ave. Glendora; CA 91740; EU Rep: Kerr Italia; S.r.l; Via Passanti; 332; 1-84018 Scafati (SA); Italy; Made in TaiwanThe intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus; for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

Zimmer; Inc. Jun-14-2013 Zimmer Patient Helper Bed Frame Adapter Assembly – Zimmer Patient Helper Bed Frame Adapter AssemblyThe bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient’s mobility within a hospital bed and during bed ingress and egress. The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.

Biomet; Inc. Jun-15-2013 Phoenix Retrograde Femoral Nail – Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems.Product Usage:The Phoenix Retrograde Femoral Nail is indicated for alignment; stabilization; and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt; which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su

Philips Healthcare Inc. Jun-17-2013 Philips Digital Diagnost – Philips Diagnost Stationary Radiographic SystemModels: 712020; 712022; 712050; 712052; 712055; 712057; 712062Product Usage:Universal RAD Applications Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Testcould not be located or different templates have been used

Biomet; Inc. Jun-17-2013 Superior Approach Resection Guide Assembly – Superior Approach Resection Guide Assembly.Indicated for primary; fracture; or revision total shoulder replacement for the relief of pain. Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction.When the slot on the resection guide is offset in the wrong direction; the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

Philips Healthcare Inc. Jun-17-2013 Philips Digital Diagnost – Philips Diagnost Stationary Radiographic SystemModels: 712020; 712022; 712050; 712052; 712055; 712057; 712062Product Usage:Universal RAD Applications Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment.

Philips Healthcare Inc. Jun-17-2013 Philips Bucky Diagnost – Philips BuckyDiagnost Radiographic; a Diagnostic X-ray system.Catalog Numbers: 704031; 704032; 704035; 704060; 704062This system is used for making x-ray exposures for diagnostics. An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used

Philips Healthcare Inc. Jun-17-2013 Philips Bucky Diagnost – Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031; 704032; 704035; 704060; 704062This system is used for making x-ray exposures for diagnostics An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment

Aperio Technologies Inc Jun-17-2013 Aperio ScanScope System – Aperio ScanScope System. Aperio ScanScope Models; XT; AT; AT Turbo; CS and CSO.Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides. Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.

IDEV Technologies; Inc. Jun-18-2013 SUPERA VERITAS – IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms There was an error on the outer labeling of this device. The inner label was correct.

GE Healthcare; LLC Jun-18-2013 GE Healthcare; PET VCAR – GE Healthcare; PET VCAR.PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6; Volume Share 5 enhanced vxtl.11.3; vxtl.11.3 ext1; or vxtl.11.3 ext2 AW Server 2.0; Volume Share 5 enhanced vxtl.11.3; vxtl.11.3 ext1; or vxtl.11.3 ext2PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis; staging; treatment planning and monitoring treatment response. GE Healthcare has recently become aware of a potential safety issue with respect to the automated PERCIST response criteria calculation applied in the PET VCAR application on Advantage Workstation or AW Server.

Tecan US; Inc. Jun-19-2013 Freedom EVO 2 with TouchTools Suite Version 3.0 – Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument. WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode; door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open; the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t

Synthes USA HQ; Inc. Jun-19-2013 Synthes 11-Hole; 1/3 Tubular Plate DCL Plate with Collar – Synthes 11-Hole; 1/3 Tubular Plate DCL Plate with Collar; Part Number 241.000.011 The Synthes One-Third Tubular DCL Plate (11-Hole; 1/3 Tubular Plate w/Collar); was released to the United States market in error. This action is not being initiated as a result of adverse events.

Prism Medical Services USA Jun-19-2013 BC Hammock Mesh Sling – BC Hammock Mesh Sling (Large); product number; 537030.Product Usage:The fabric sling is used for the transfer of a patient; for example from a bed to a wheelchair. The product does not meet the firm’s size standards; the product was produced in the incorrect size.

Prism Medical Services USA Jun-19-2013 BC Hammock Mesh Sling – BC Hammock Mesh Sling (Small); product number; 537010. Product Usage:The fabric sling is used for the transfer of a patient; for example from a bed to a wheelchair. The product does not meet the firm’s size standards; the product was produced in the incorrect size.

Prism Medical Services USA Jun-19-2013 BC Hammock Mesh Sling – BC Hammock Mesh Sling (Medium); product number; 537005. Product Usage: Usage:The fabric sling is used for the transfer of a patient; for example from a bed to a wheelchair. The product does not meet the firm’s size standards; the product was produced in the incorrect size.

Hitachi Medical Systems America Inc Jun-19-2013 Echelon; Echelon Oval and Oasis MR imaging device systems – Echelon; Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon; Echelon Oval and Oasis MR systems are imaging devices; and are intended to provide the physician with physiological and clinical information; obtained non-invasively and without the use of ionizing radiation. The MR systems produce transverse; coronal; sagittal; oblique; and curved cross-sectional images that display the internal structure of the head; body; or extremities. Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the processed dataset to have the same unique identifier (UID) as in the scanning dataset. The processed image is stored in the place of the original image; which is lost.

Prism Medical Services USA Jun-19-2013 BC Hammock Mesh Sling – BC Hammock Mesh Sling (Junior); product number; 537005. Product Usage:The fabric sling is used for the transfer of a patient; for example from a bed to a wheelchair. The product does not meet the firm’s size standards; the product was produced in the incorrect size.

Ortho-Clinical Diagnostics Jun-19-2013 VITROS Clinical Chemistry Products Homocysteine (HCY) Reagent – VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma. The firm is recalling the specific lot due to lower than expected results.

Linde Gas North America Llc Jun-20-2013 MEDICYCL-E- Lite Portable Oxygen System – MEDICYCL-E- Lite Portable Oxygen SystemAn integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe; MRI-compatible; and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications; Rx only. A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.

Prism Medical Services USA Jun-21-2013 C-Series Carry Bar – Prism Medical C-Series Carry Bar; Class I; model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift; transfer or position clients. The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.

Loma Vista Medical Jun-21-2013 TRUE Dilatation Balloon Valvuloplasty Catheter – TRUE Dilatation Balloon Valvuloplasty Catheter; REF Numbers: 02045-11; 02245-12; 02445-12; and 02645-13; Sizes: 20mm x 4.5cm; 22mm x 4.5cm; 24mm x 4.5cm; and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty. Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.

Baxter Healthcare Corp. Jun-21-2013 MiniCap with Providone-Iodine solution – Baxter; MiniCap with Povidone-Iodine solution; 5C4466P; Baxter Healthcare Corporation; Deerfield; IL 30015 USA.Intended to isolate the Easy-Lock connector of the solution transfer set. leaking pouches

Medtronic Inc. Cardiac Rhythm Disease Management Jun-21-2013 Launcher Coronary Guiding Catheter – Medtronic; Launcher Guiding Catheter; Model # LA8EBU45SH; Lot # 0006722866; 8F and Model # LA6IMAD; Lot # 0006724224; 6FProduct Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system. Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.

Becton Dickinson & Company Jun-21-2013 BD SafetyGlide Allergy Syringe Tray – BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications. There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.

Terumo Cardiovascular Systems Corporation Jun-21-2013 Sarns " TCM II Temperature Control Module – Sarns " TCM II Temperature Control ModuleThe Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.

Maquet Cardiovascular Us Sales; Llc Jun-21-2013 Maquet – MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures. The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.

Siemens Medical Solutions USA; Inc Jun-21-2013 SIEMENS ARTISTE – ARTISTE with syngo RT Therapist version 4.3Product Usage:The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The potential for a safety issue; for the image quality degradation; that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.

GE Healthcare; LLC Jun-21-2013 CARESCAPE Monitor B850 – CARESCAPE Monitor B850Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult; pediatric; and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics; Airway Gases (Fi/Et CO2; O2; N2) and Anesthetic Agent); Spirometry; Gas Exchange (O2 Consumption (VO2); CO2 production (VCO2); energy expenditure (EE); and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG); Entropy; Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure; CARESCAPE Monitor B850 unstable USB communication; CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.

Microgenics Corporation Jun-21-2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems – Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems; ; Product is manufactured and distributed by Microgenics Corporation; Fremont; CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. It has been confirmed from in-house testing that Direct Bilirubin (DBIL); and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

GE Healthcare It Jun-24-2013 Centricity Laboratory Core Lab; Versions 3.3; 4.0; 4.1 – The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities; e.g.; the storing and delivering of analytical results. It is a specially designed data program application (software); which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run; steer; or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities; including a central laboratory or in a multiple laboratory environment servicing satellite laboratories; reference laboratories; clinics; etc. Centricity Laboratory System is not intended for direct patient contact. If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values; in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form; some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl

Roche Diagnostics Operations; Inc. Jun-24-2013 CoaguChek XS System (HCP) – CoaguChek XS System (HCP)The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS; CoaguChek XS Plus; and CoaguChek XS Pro meters. In rare cases; instead of a value; an ERROR 6 message is displayed.

Roche Diagnostics Operations; Inc. Jun-24-2013 CoaguChek XS Plus System – CoaguChek XS Plus SystemThe CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS; CoaguChek XS Plus; and CoaguChek XS Pro meters. In rare cases; instead of a value; an ERROR 6 message is displayed.

Roche Diagnostics Operations; Inc. Jun-24-2013 CoaguChek XS System (PST) – CoaguChek XS System (PST)The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin. Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS; CoaguChek XS Plus; and CoaguChek XS Pro meters. In rare cases; instead of a value; an ERROR 6 message is displayed.

U-systems Inc Jun-24-2013 Soma v Automated Breast Ultrasound System – Soma v Automated Breast Ultrasound System (ABUS); Automated Breast Ultrasound.Indicated as an adjunct to mammography for breast cancer screening. Devices labeled for an intended use not included in the existing 510(k) or PMA; in that; the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

Roche Diagnostics Operations; Inc. Jun-24-2013 CoaguChek XS Pro System – CoaguChek XS Pro SystemThe CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"); using capillary blood or whole blood from a vein (non anticoagulated venous whole blood). Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS; CoaguChek XS Plus; and CoaguChek XS Pro meters. In rare cases; instead of a value; an ERROR 6 message is displayed.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft;LARGE II KIT; REF 7510800; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Philips Medical Systems (Cleveland) Inc Jun-25-2013 The Brilliance 64; Ingenuity CT; Ingenuity Core; and Ingenuity Core128 scanners – Brilliance CT 64; Ingenuity CT; Ingenuity Core; and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also; it is possible to begin a normal clinical scan while the anti-virus scan is running. However; if the user is running a bol

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; LARGE II KIT; REF 7510800AUS; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; MEDIUM KIT; REF 7510400AUS; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; SMALL KIT; REF 7510200AUS; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; LARGE KIT; REF 7510600; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; MEDIUM KIT; REF 7510400; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medtronic Sofamor Danek USA Inc Jun-25-2013 INFUSE(R) Bone Graft – INFUSE(R) Bone Graft; SMALL KIT; REF 7510200; Medtronic Sofamore Danek USA; Inc.; 1800 Pyramid Place; Memphis; Tennessee 38132orthopaedic Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

Medrad Inc Jun-25-2013 DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor – DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage:Monitor; Physiological; Patient The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.

RF Technologies; Inc. Jun-26-2013 Code Alert; Sensatec – Code Alert Advanced 4-Way Care Solution; CA520 System;PN 9600-1600; RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. RF Technologies; Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error; the alarm may not be transmitted to the system server immediately.

Steris Corporation Jun-26-2013 Quick Connect – Quick Connect QLC1677E; QRC1699E; QPC1721E and QFC1683E. STERIS Corporation; Mentor; OH 44060QLC1677E; QRC1699E; QPC1721E and QFC1683E contain processing instructions; a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card; tubing; tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers. During a routine label review; the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.

GE Healthcare; LLC Jun-26-2013 GE Healthcare Senographe Essential System – GE Healthcare Senographe Essential System.The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems. GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions associated with the defective Operator Manual CD of the Senographe Essential.

ConBio; a CynoSure Company Jun-26-2013 RevLite SI Laser – Multilite Dye Handpieces; an optional accessory of the RevLite SI Laser.The Revlite SI laser is intended for General Dermatology; Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal; pigmented lesion removal; removal or lightening of hair; skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by:ConBio; A Cynosure Company47733 Fremont blvdFremont; CA 94538 An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.

Beckman Coulter Inc. Jun-27-2013 Synchron System(s) Lactate Reagent – Synchron System(s) Lactate ReagentProduct Usage: Lactate (LACT) reagent; when used in conjunction with Synchron LX¿ System(s); UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator; is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF). Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration witherror condition OCR LOW. The calibration failures appear to be related to improper shipping orstorage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump Intermate Infusion Pump – Brand Name: Intermate Infusion Pump.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump Regional Analgesia Infusor System – Brand Name: Regional Analgesia Infusor System with Patient Control.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump Multirate Infusor Devices – Brand Name: Multirate Infusor Devices.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Medtronic Inc. Cardiac Rhythm Disease Management Jun-27-2013 Medtronic; Consulta¿ CRT-P – Medtronic; Consulta¿ CRT-P; Model C4TR01; C3TR01 (not approved for US); and Syncra¿ CRT-P; Model C2TR01; Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. Medtronic recently identified an issue with a subset of Consulta? CRT-P and Syncra? CRT-P devices during production. As of May 30; 2013; there have been no reported or confirmed device failures. However; because of the potential for malfunction; Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13; 2013 for re-inspection. The issue is unique to specifi

Baxter Healthcare Corp. Jun-27-2013 Infusion Pump – Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter’s Infusor SV Elastomeric Infusion Device Device Listing: D020871Baxter’s lnfusors SV Elastomeric Infusion Device is a single-use; disposable elastomeric infusion pump indicated tor patients requiring slow; continuous intravenous; intra-arterial; subcutaneous; or epidural administration of medications at a constant flow rate. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in t

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump SV Elastomeric Infusion Device – Brand Name: SV Elastomeric Infusion Device.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump Infusor SV and LV Elastomeric Infusion Devices – Brand Name: Infusor SV and LV Elastomeric Infusion Devices.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. Jun-27-2013 Infusion Pump – Brand Name: Coiled Tube Infusors. Multiday lnfusor; Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h; Single Day INFUSOR 2 ml/h System; Half Day INFUSOR SV 5 ml/h System; Two Day INFUSOR 2 ml/h System; Two day Infusor 2 ml/h; Two Day INFUSOR 2ml/h System; Multiday Infusor 0.5 ml/h; Multiday INFUSOR 0.5ml/h System; Seven Day Infusor 0.5 ml/h; Seven Day INFUSOR 0.5ml/h System; Basal-Bols Infusor-15min.; Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout; Basal-Bolus Infusor Device Listing: D018045The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow; continuous intravenous; intra-arterial; subcutaneous or epidural administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. Complaint rates for leaks have since decreased. Baxter wants to ensure that no affected product remains in t

Baxter Healthcare Corporation Jun-27-2013 Infusion Pump Basal/Bolus Infusor – Brand Name: Basal/Bolus Infusor.Indicated for the intravenous administration of medications. Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Terumo Medical Corporation Jun-27-2013 Pinnacle¿ Destination¿ Peripheral Guiding Sheath – Pinnacle¿ Destination¿ Peripheral Guiding Sheath; 8 French; 90cm; Straight Tip; Cross Cut Valve.Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. Medical devices were incorrectly labeled with extended expiration dates.

Terumo Medical Corporation Jun-27-2013 Terumo Glidesheath – Terumo Glidesheath ™; 6 French; Nitinol wire; product code 15-1060.Used to facilitate placing a catheter through the skin into a vein or artery. Medical devices were incorrectly labeled with extended expiration dates.

Greatbatch Medical Jun-27-2013 Cordis Radial Source Spring Wire Transradial Access Kit Product – Cordis a Johnson & Johnson Company; RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North; Minneapolis; MN 55441; Distributor Cordis Corporation 14201 North West 60th Avenue; Miami Lakes; Florida 33014.Baxter’s lnfusors SV Elastomeric Infusion Device is a single-use; disposable elastomeric infusion pump indicated tor patients requiring slow; continuous intravenous; intra-arterial; subcutaneous; or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting. Cordis Corporation; Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip; too small to slide over the guidewire.

Bard Access Systems Jun-28-2013 StatLock – StatLock CV Plus w/Pigtail; Catheter Stabilization Device Sterile EO Single Use Only; C.R. Bard; Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters. BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet

GE Healthcare; LLC Jun-28-2013 GE Healthcare; Innova 3100 and Innova 4100 systems – GE Healthcare; Innova 3100 and Innova 4100 systems.The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. GE Healthcare reported a potential safety issuedue to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

Biosense Webster; Inc. Jun-28-2013 20-Pole LASSO Nav Catheter Eco – 20-Pole LASSO Nav Catheter Eco; Catalog # D-1349-02S.Designed to facilitate electrophysiological mapping of the atria of the heart. Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.

Medical device recalls for June 2013

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