Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan Synergies Plus Negative Urine Combo 2Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan Synergies Plus Negative Urine Combo 5Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan plus Negative Urine Combo 4Sold outside of US only.Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan plus Negative Breakpoint Combo 4Sold outside of US only.Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – MicroscanrapID/S panels NC3.11Sold in Japan only. Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan rapID/S panels NC3.12Sold in Japan only. Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan rapID/S panels NC3.33Sold in Japan only. Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan Synergies Plus Negative Breakpoint Combo 7Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan Synergies Plus Negative Combo 2Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan Synergies Plus Negative Urine Combo 1Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
Siemens Healthcare Diagnostics; Inc. Sep-11-2013 MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – Microscan plus Negative Combo 3Sold outside of US only.Product Usage:MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) – For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or meropenum on Synergies plus Negative and rap ID/S plus Negative panels read on Walk Away System.
B Braun Medical; Inc. Sep-13-2013 Outlook ES Safety Infusion System – Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump); and provides clinically accepted volumetric accuracy for all standard IV fluids; including blood; lipid; and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26; 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to advance as if the pump were infusing. The pump emits a backup alarm; but there are no visual indicators that the infusion
Carefusion 211 Inc dba Carefusion Sep-27-2013 AVEA¿ Ventilator – Product Name: AVEA¿ Ventilator.All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device.A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult; pediatric; and neonatal ventilators are included in this generic type of device. CareFusion has identified a potential risk associated with AVEA? ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation.CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
King Systems Corp. Sep-27-2013 Universal Flex2 Breathing Circuit – Universal Flex2 Breathing CircuitClass I 510(k) ExemptAn anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector; adaptor; and Y-piece. King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag; but was labeled as non-latex.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Boston Scientific Corporation Sep-03-2013 Boston Scientific; Small Peripheral Cutting BalloonTM – Boston Scientific; Small Peripheral Cutting BalloonTM; Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device; UPN #001BPM4015140F0; Catalogue # BPM4015140F & UPN # M001PCBM4015140F0; Catalogue # PCBM4015140F.2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device; UPN # M001PCBO4015140F0; Catalogue # PCBO4015140F. Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
Boston Scientific Corporation Sep-03-2013 Boston Scientific; FlextomeTM Cutting BalloonTM – Boston Scientific; FlextomeTM Cutting BalloonTM; Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device; UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device; UPN # H749CBO3400150; Catalogue # CBO340015The Flextome Cutting Balloon Device is indicated for dilatation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition; the target lesion should possess the following characteristics: " Discrete (< 15 mm in length); or tubular (10 to 20 mm in length) " Reference vessel diameter (RVD) of 2.00 mm – 4.00 mm " Readily accessible to the device " Light to moderate tortuosity of proximal vessel segment " Nonangulated lesion segment (< 45¿) " Smooth angiographic contour " Absence of angiographically visible thrombus and/or calcification. Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
DePuy Spine; Inc. Sep-03-2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT – CONFIDENCE SPINAL CEMENT SYSTEM KIT; Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. During injection of cement; the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
DePuy Spine; Inc. Sep-03-2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT – CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT; Product Code: 2839-05-000The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. During injection of cement; the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
DePuy Spine; Inc. Sep-03-2013 CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT – CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT; Product Code: 2839-10-000The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures During injection of cement; the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula PouchProduct Number: CS-100 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula PouchProduct Number: CS-50 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula – LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no CannulaProduct Number: PV-100LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula – LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no CannulaProduct Number: PV-250 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula PouchProduct Number: LG50LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula PouchProduct Number: LG100LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula PouchProduct Number: LG250 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Internal Vessel Occluder .25mL – LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 Le Goo – LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Internal Vessel Occluder 1mL – LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Internal Vessel Occluder 2.5mL – LeGoo Internal Vessel Occluder 2.5mLProduct Number: 10-0250LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Internal Vessel Occluder 5mL – LeGoo Internal Vessel Occluder 5mLProduct Number: 10-0500LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Internal Vessel Occluder 10mL – LeGoo Internal Vessel Occluder 10mLProduct Number: 10-1000LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Endovascular Occlusion Gel 0.5 mL – LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50ITLeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Endovascular Occlusion Gel 1.0 mL – LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100ITLeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo Endovascular Occlusion Gel 2.5 mL – LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250ITLeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula – LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no CannulaProduct Number: PV-50 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Siemens Healthcare Diagnostics Sep-03-2013 ADVIA Chemistry A1c_3 Calibrators – ADVIA Chemistry A1c_3 Calibrators; Catalog Number 10491408; IVD — COMMON/USUAL NAME: ADVIA Chemistry A1c_3 CalibratorsShipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g — Siemens Healthcare Diagnostics; Inc. Tarrytown; NY 10591 — System Information: The ADVIA Chemistry systems are automated; clinical chemistry analyzers that can run tests on human serum; plasma; or urine in random access and batch modes for in vitro diagnostic use.For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems. Siemens confirmed that the ADVIA? Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014; 1BD063; and 2GD014. The established ranges of CAP Survey Samples GH2-04; GH2-05 and GH2-06 and IFCC sample recoveries use ? 7% from the established mean as their acceptance criteria. This is the crite
Genzyme Corporation; A Sanofi Company Sep-03-2013 LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch – LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula PouchProduct Number: CS-25 LeGoo is a water-soluble; biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck. Product contains particulates (fibers)
Stelkast Co Sep-03-2013 SC2316; Distal Femoral Augment with Screw – SC2316; Distal Femoral Augment with ScrewTotal knee replacement due to osteoarthritis; osteonecrosis; rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions. The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316; Distal Femoral Augment with Screw.
Elekta; Inc. Sep-04-2013 Elekta DMLC – DMLC IV-ERGO – Beam shaping block for Radiation Therapy. Clinical mistreatment may occur when there are errors in the clinical work flow.
MicroAire Surgical Instruments; LLC Sep-04-2013 Steinmann Pin – Steinmann Pin; packed in a clear tube with end caps; tubes packed in a sterile barrier pouch; 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville; VA LLC 22911***Models:1620-109 1636-5091620-509 1640-5091620-609 1648-5091620-709 1648-509T1624-109 1648-6091624-509 1648-609T1624-509T1628-5091632-5091632-609A smooth or threaded wire / pin that may be used for fixation of bone fractures; for bone reconstructions; as a guide pin for insertion of other implants; or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
MicroAire Surgical Instruments; LLC Sep-04-2013 Kirschner-Wire (K-Wire); – Kirschner-Wire (K-Wire); packed in a clear tube with end caps; tubes packed in a sterile barrier pouch; 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville; VA LLC 22911***Models:1620-109 1636-5091620-509 1640-5091620-609 1648-5091620-709 1648-509T1624-109 1648-6091624-509 1648-609T1624-509T1628-5091632-5091632-609A smooth or threaded wire / pin that may be used for fixation of bone fractures; for bone reconstructions; as a guide pin for insertion of other implants; or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
B Braun Medical; Inc. Sep-06-2013 Outlook ES Safety Infusion System – Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of deliveringfluid from a negative head height (when the IV fluid container is lower than the pump); and provides clinically accepted volumetric accuracy for all standard IV fluids; including blood; lipid; and Total Parenteral Nutrition (TPN). Model number: 621-100ES; 621-200ES; 621-300ES; and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs; the Door Processor (DP) will not receive the desired input from the user. This issue can be observed in pumps with key panels
Baxa Corporation Sep-06-2013 Baxa Vial Adapter; 14mm – Luer Lock – Baxa Vial Adapter; 14mm – Luer Lock; Order No. REF: 90; Quantity: 50 each; Single Use. Product Code H93890.Used as a needleless access device for reconstitution and drug transfer. Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters; 14mm – Luer Lock; due to incorrect expiry date.
B. Braun Medical; Inc. Sep-06-2013 B. Braun Outlook Safety Infusion System Burette Set – Outlook Safety Infusion System Burette Set.For intravenous fluid administration. Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038); and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
B Braun Medical; Inc. Sep-06-2013 Outlook ES Safety Infusion System – Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of deliveringfluid from a negative head height (when the IV fluid container is lower than the pump); and provides clinically accepted volumetric accuracy for all standard IV fluids; including blood; lipid; and Total Parenteral Nutrition (TPN). Model number: 621-100ES; 621-200ES; 621-300ES; and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August; 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This occurs when a sequence of HOLD – HOLD key strokes are performed on the pump key panel while the user is in the Dose Dat
GE Healthcare; LLC Sep-06-2013 Tec 6 Plus Vaporizer – Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold. GE Healthcare has recently become aware of a potential safety issue involving the pre-operative check; low pressure leak test at 1% dial setting of the Tec 6 and Tec 6 Plus Vaporizers. The user manual pre-operative check; low pressure leak test may not detect the full range of leaks from seal wear degradation in the vaporizers. If the leak is not detected; it will result in fresh gas leaking to
Medical Indicators; Inc. Sep-06-2013 Tempa DOT – Tempa DOT Single-Use Clinical Thermometer Medical IndicatorsMade in U.S.A. by Medical Indicators; Inc. 16 Thomas J Rhodes Industrial Drive; Hamilton; NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.comPer 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806; TempaDOT thermometers are individually wrapped; single-use; disposable clinical thermometers for oral or axillary use. TempaDot products may have been mislabeled.
Xlumena; Inc. Sep-09-2013 Xlumena brand NAVIX Access Device – Xlumena brand NAVIX Access Device; Model/Catalogue Number: NVX-10-03; Part Number: FG-00666; Product is manufactured and distributed by Xlumena; Inc.; Mountain View; CAThe NAVIX Access Device is a multi-lumen balloon catheter with a trocar; anchor balloon; and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst; when it is visibly bulging into the gastrointestinal tract during endoscopic procedures. A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Berchtold Corp. Sep-09-2013 OPERON D850 Surgical Table – OPERON D850 Surgical TableProduct Usage: Surgical Table Table was not lowering.
Roche Molecular Systems; Inc. Sep-10-2013 KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD; CE-IVD – KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD; CE-IVDRoche Molecular System; Inc. 1080 US highway 202 South Branchburg; NJ 08876 USARoche Diagnostics 9115 Hague Road Indianapolis; IN 46250-0457 USAThe cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31; 33; 35; 39; 45; 51; 52; 56; 58; 59; 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results; to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information; together with the physicians assessment of cytology history; other risk factors; and professional guidelines; may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older; the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information; together with the physicians assessment of cytology history; other risk factors; and professional guidelines; may be used to guide patient management. (d) In women 30 years and older; the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information; together with the physicians assessment of cytology history; other risk factors; and professional guidelines; may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula During an internal investigation; a formulation error that occurred was identified during the manufacture of the cobas? 4800 HPV Master Mix reagent that was packaged in four (4) cobas? 4800 AMP/DET kits; US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
B Braun Medical; Inc. Sep-10-2013 Outlook ES Safety Infusion System – Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump); and provides clinically accepted volumetric accuracy for all standard IV fluids; including blood; lipid; and Total Parenteral Nutrition (TPN). Model number: 621-100ES; and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets. B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. This could have led to a delay in therapy; or to delivery of an over or under-dose of a therapy if the user was to rely on
Siemens Healthcare Diagnostics; Inc Sep-10-2013 ADVIA Centaur Folate – ADVIA Centaur Folate (2500 tests); REF SMN 10340209; Cat No. 09132781In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Siemens Healthcare Diagnostics; Inc Sep-10-2013 ADVIA Centaur Folate – ADVIA Centaur Folate (100 Tests); SMN 10310308; Cat No. 06367974In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Siemens Healthcare Diagnostics; Inc Sep-10-2013 ADVIA Centaur Folate – ADVIA Centaur Folate (500 Tests) SMN 10325366; Cat No. 06891541In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Siemens Healthcare Diagnostics; Inc Sep-10-2013 ADVIA Centaur Folate – ADVIA Centaur Folate (500 tests); REF SMN 10331250; Cat No. 00203473In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
Covidien LLC Sep-10-2013 Covidien – Monoject 0.9% Sodium Chloride Flush Syringe; 12 mL Syringe with 10 mL FillProduct ID: 8881570121Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 100 Units/mL Heparin Lock Flush; 12 mL Syringe with 5 mL FillProduct ID: 8881590125Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Advanced Sterilization Products Sep-10-2013 STERRAD – STERRAD 100NX Cassettes; Product Code: 10144The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging’s leak indicator for the entire duration of the STERRAD 100 NX System cassette’s 15 month shelf life.
Covidien LLC Sep-10-2013 Covidien – Monoject 0.9% Sodium Chloride Flush Syringe; 12 mL Syringe with 3 mL FillProduct ID: 8881570123Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 0.9% Sodium Chloride Flush Syringe; 12 mL Syringe with 5 mL FillProduct ID: 8881570125Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 10 Units/mL Heparin Lock Flush; 12 mL Syringe with 10 mL FillProduct ID:8881580121Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 10 Units/mL Heparin Lock Flush; 12 mL Syringe with 3 mL FillProduct ID: 8881580123Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 10 Units/mL Heparin Lock Flush; 12 mL Syringe with 5 mL FillProduct ID: 8881580125Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 100 Units/mL Heparin Lock Flush; 12 mL Syringe with 10 mL FillProduct ID: 8881590121Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Covidien LLC Sep-10-2013 Covidien – Monoject 100 Units/mL Heparin Lock Flush; 12 mL Syringe with 3 mL FillProduct ID: 8881590123Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile; single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
Leica Microsystems (Schweiz) Ag Sep-10-2013 Leica M525 OH4 – Surgical microscopeThe device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment. The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
Leica Microsystems (Schweiz) Ag Sep-10-2013 Leica M720 OH5 – Surgical microscopeThe device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment. The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
Cardiogenesis Corporation Sep-11-2013 Cardiogenesis Transmyocardial the SoloGrip III (HP-5G3) and the PEARL 5.0 (HP-PRL5). – Cardiogenesis Corporation – Cardiogenesis Transmyocardial Laser.The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization. Following acquisition of Cardiogenesis; we began receiving complaints of sparks; burns; or smoke incidents related to the handpieces.
HemoCue AB Sep-11-2013 HemoCue¿ Glucose 201 Microcuvettes – HemoCue¿ Glucose 201 Microcuvettes; 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer; the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
Edwards Lifesciences; LLC Sep-11-2013 FloTrac Sensor – "***Flo Trac Sensor Model MHD85***"Sterile; single use kit that monitors pressures when attached to pressure monitoring catheters. The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
Carefusion 2200 Inc Sep-11-2013 *** 1) Thoracentesis Tray; *** 2) Safe-T Thoracentesis Tray – *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park; IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park; IL 60085 USA.Indicated for specimen retrieval and therapeutic drainage of the pleural cavity. Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray – Drug Free may occlude; preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
Becton Dickinson & Company Sep-11-2013 BD Microtainer Quikheel Lancet – BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton; Dickinson and Company; Franklin Lakes; NJ 07417 USA Made in USA.Used to perform heel sticks for the purpose of collecting skin puncture blood. The Lancet will not retract after activation thus creating a potential for exposure to a used sharp.
Spine Wave; Inc. Sep-11-2013 StaXx¿ IB Convex Expandable Implant – StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm); Intervertebral Fusion Device; Lumbar; Catalog Number 11 -1902.Indicated for intervertebral body fusion procedures in skeletally mature patients. A component Superior endplate manufactured from a different polymer than specified
Lumenis; Inc. Sep-11-2013 Vision One Laser System Model – Vision One Laser System Model GA-0025020; Serial No: 10050; 10051; 10053.Intended for use in the treatment of ocular pathology. Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
Ormco/Sybronendo Sep-12-2013 Brand Name: Vector TAS 8mm Screw. – Brand Name: Vector TAS 8mm Screw.The Device Listing Number is E670535.Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices. Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued; possibly requiring surgical removal of any remaining pieces.
Sybron Dental Specialties Sep-12-2013 AOA Mini RPE Screw Assembly – AOA Mini RPE Screw Assembly ; a component ofHerbst; MARA and Fixed Metal devices.Product Usage:AOA Mini RPE Screw Assembly is a component of Herbst; MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern; however; this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer; Screw Expansion; Orthodontic. The firm initiated the recall of AOA Mini RPE Screw Assembly; because it may be missing a complete weld joining one side of the arm with the screw body. Herbst; MARA and Fixed Metal devices may be affected; because they contain an AOA Mini RPE Screw Assembly.
Tornier; Inc Sep-13-2013 AEQUALIS Reversed II or AEQUALIS Fracture Impactor. – AEQUALIS Reversed II or AEQUALIS Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21; MWD023; MWD024 and MWD025.The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere; poly insert; spacer; and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly. Following the identification of the disassociation of an impactor tip during surgery; Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event; Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
Assuramed Sep-13-2013 Hemoccult II SENSA elite – Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide; 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter; Inc.; 250 S. Kraemer Blvd.; Brea; CA 92821The Hemoccult II SENSA elite test is a rapid; convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations; for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery; peptic ulcer; ulcerative colitis and other conditions; and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens. The products may have been stored at temperatures outside their required storage conditions.
Assuramed Sep-13-2013 DiaScreen Liquid Urine Controls – DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4×12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA; Inc.; Minneapolis; MN 55439Diascreen liquid urine control is a synthetic control designed to react with commercial urine dipsticks to register listed responses on color reagent pads. It is intended for use in a clinical laboratory as a urine control for qualitative procedures used in chemical determinations. The control is intended to be used exactly as if it were a patient sample to assist in the assessment of the listed analytical procedures. The products may have been stored at temperatures outside their required storage conditions.
Assuramed Sep-13-2013 ProTime Microcoagulation System – ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 – 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic; gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison; NJ 08820 USA; a subsidiary of Thoratec CorporationThe ProTime Microcoagulation System consists of a portable; battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing. The products may have been stored at temperatures outside their required storage conditions.
Villa Radiology Systems LLC Sep-13-2013 Juno DRF System – Juno DRF System. Mobile X-ray systemThese are general; multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30×30 (12"x12") and 15×15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
Medtronic Sofamor Danek USA Inc Sep-14-2013 T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System – T8 REMOVAL HEAD; REF 8910641; QTY: 1 EA; Product Usage:The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device. One lot of the T8 Removal Head had incorrect hardness specification; which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
GE Healthcare; LLC Sep-16-2013 GE Healthcare; CARESCAPE Monitor B850 – GE Healthcare; CARESCAPE Monitor B850.Intended for use in multiple areas within a professional healthcare facility. GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR; SpO2 or Invasive pressure alarm limits from the iCentral over the network; the alarm priority on th
Philips Medical Systems (Cleveland) Inc Sep-16-2013 Brilliance CT 6; Brilliance CT 16; Brilliance CT 40; & Brilliance CT 64 – Brilliance CT 6; M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40; M/N 728235 & Brilliance CT 64 M/N 728231; Philips Healthcare; Cleveland; OH 44143.Intended to produce cross-sectional images of the body by computer reconstruction. The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
Biomet 3i; LLC Sep-16-2013 Osseotite; 2Certain; Prevail – Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental ImplantProduct Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Biomet 3i; LLC Sep-16-2013 Osseotite; Parallel Walled Certain – Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental ImplantProduct Usage: Surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Camlog Usa Sep-16-2013 CONELOG Titanium Base – C2244.5008 CONELOG Titanbasis CAD/CAMConelog Titanium Base CAD/CAM Rx only¿5.0GH 0.8 inkl HSProduct Usage:Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. Product not cleared for sale/use in the United States.
Cincinnati Sub-Zero Products Inc Sep-16-2013 Blanketrol III; Model Number 233 – Blanketrol III; Model Number 233; Cincinnati Sub-Zero Products; Inc.; 12011 Mosteller Road; Cincinnati; OH 45241Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer. During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval.
Camlog Usa Sep-16-2013 CONELOG Titanium Base – C2244.3820;; CONELOG Titanium Base CC ¿3.8GH2.0 inkl HSProduct Usage:Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. Product not cleared for sale/use in the United States.
Camlog Usa Sep-16-2013 CONELOG Titanium Base – C2244.3808; CONELOG Titanium Base CC ¿3.8GH0.8 inkl HSProduct Usage:Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. Product not cleared for sale/use in the United States.
Sonogage Inc Sep-16-2013 A-Scan Biometer – Sonogage EyeScan; A-Scan Biometer; Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length. During an FDA inspection on 7/15-26/2013; it was discovered that the firm lacked registration and 510(k) clearance for the device.
Camlog Usa Sep-16-2013 CONELOG Titanium Base – C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HSProduct Usage:Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. Product not cleared for sale/use in the United States.
Rauland-Borg Corp Sep-17-2013 Responder 5 – Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology; physical therapy; transport; environmental services and more.Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers A counterfeited electronic component was identified in the products affected. The component; a data transceiver (transmitter/receiver); is associated with the intercommunication of these devices in the Responder 5 system across the L-Net data path. Failure of a data transceiver results in the loss of nurse call functionality in the associated room; and may disrupt communications on the L-Net run
Zeppessis Reprocessing; LLC Sep-17-2013 Stryker Neptune 1 and Neptune 2 Waste Management Systems – Zeppessis’ reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems:The Neptune Waste management system is intended to be used in the Operating Room; Surgical Centers and Doctor’s Offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautory or laser devices. ***The single-port manifold for the Stryker Neptune 1 (part # 700-015-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 1 (part # 700-020-000) can be used with the: Neptune 1 Gold Rover or the Neptune Bronze Rover as an accessory to Class 2 Air-handling apparatus for a surgical operating room (Sec. 878.5070); or with the Neptune 1 Silver Rover as an accessory to Class 2 Powered suction pump. ***single-port manifold for the Stryker Neptune 2 (part # 702-025-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. ***four-port manifold for the Stryker Neptune 2 (part # 702-020-000) can be used with the Neptune 2 Rover Ultra as an accessory to Class 2 Powered suction pump. Zeppessis’ reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.
Ebi; Llc Sep-17-2013 Multiaxial Translating MIS Screw – Cypher MIS Screw System; Biomet Spine Parsippany; NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device.1)Screw Tower – REF 14-5016602) Rod Reduce – REF 14-5016613) Counter Torque – REF 14-501662 Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Implantech Associates Inc Sep-17-2013 Terino Square chin-Style II-Medium – Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M.To augment or reconstruct underdeveloped or traumatized mandibular region. Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156); after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture; Blue; Part Number: 72201993Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; White / Blue ; Part Number: 72201995Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture; White; Part Number: 72201991Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture; Black; Part Number: 72201992Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture; Blue; Part Number: 72201994Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; White / Black; Part Number: 72201996Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; White; Part Number: 72202165Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture; Black; Part Number: 72203291Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 Osteoraptor Suture Anchor – OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture; Blue; Part Number: 72203290Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture; White / Blue; Part Number: 72202597Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture; Blue / Black; Part Number: 72202624Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture; Blue / Black; Part Number: 72202626Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture; Blue / Black; Part Number: 72202631Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture; White / Black: Part Number: 72202602Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture; White / Black: Part Number: 72202608Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue; blue-COBRAID") with Needles; Part Number: 72202612Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue; blue-COBRAID) with Needles; Part Number: 72202616Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 TWINFIX Ultra HA Suture Anchor & TWINFIX Ultra PLLA/HA Suture Anchor – TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue; blue-COBRAID) with Needles; Part Number: 72202620Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 BIORAPTOR 2.9 mm Suture Anchor – BIORAPTOR 2.9 mm Suture Anchor; pack of 1 ULTRABRAID Suture: 72200689Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 BIORAPTOR 2.9 mm Suture Anchor – BIORAPTOR 2.9 mm Suture Anchor Straight; pack of 2 ULTRABRAID Suture; Part Number: 72200690Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 BIORAPTOR 2.9 mm Suture Anchor – BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 BIORAPTOR 2.9 mm Suture Anchor – BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Smith & Nephew; Inc. Endoscopy Division Sep-17-2013 BIORAPTOR" 2.9 mm Suture Anchor – BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775Biodegradable suture anchor Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
GE Healthcare; LLC Sep-18-2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System – GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System.The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular; vascular and non-vascular; diagnostic and interventional procedures. Additionally; with the OR table; the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures. GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems.A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a largeamount of patient data remains in the browser and is not deleted. The inability to boot the system ma
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP (Base); PN 0000280000Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP 700; PN 0000280010Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP CTS; PN 0000280020Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP 700 LAS; PN 0000280030Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP 700 CTS; PN 0000280050Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP 500 CTS; PN 0000280040Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
Synthes USA HQ; Inc. Sep-18-2013 Synthes Cannulated Distal Femoral Nail (Trauma Nail) – Synthes Cannulated Distal Femoral Nail (Trauma Nail); Part Number 450.851S; 420MM-Sterile. Orthppedic implant device. Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
Instrumentation Laboratory Co. Sep-18-2013 ACL TOP Family – ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060Bench top; fully automated; random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters. Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
3M Company – Health Care Business Sep-18-2013 3M Scotchcast – 3M Scotchcast; Wet or Dry Cast Padding; Catalog Numbers WDP2; WDP3; WDP4; and WDP6.Intended for use in constructing casts for either wet or dry immobilization. 3M is conducting a voluntary product recall of selected lots of 3M" Scotchcast" Wet or Dry Cast Padding. Upon investigation of a health care provider feedback; and confirmed with internal testing; it was found that the cast padding material does not consistently repel water. Lack of repellency may result in prolonged cast dry times after exposure to wet conditions. There have been no repo
Churchill Medical Systems; Inc. Sep-18-2013 Microbore Extension Set with Bionector – Vygon 14 Microbore Extension Set with Bionector; CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. Microbore tubing disconnecting from male luers on the extension sets.
Churchill Medical Systems; Inc. Sep-18-2013 Microbore Extension Set with Bionector – Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet; Powderfree 1 Face Mask 1 Polylined Drape; 13" X 18" 1 ChloraPrep***; 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector*** 2 Dressing Sponges; 2" X 2" 1 Foam Strip; 8/5cm X 1cm 1 3M*** Tegaderm *** IV Dressing W/CHG; 2 1/2" X 4 1/2" *** Vygon MFG Dover; NH 03820***" Microbore tubing disconnecting from male luers on the extension sets.
Access Scientific Inc Sep-18-2013 POWERWAND Safety Introducer with Extended Dwell Catheter – POWERWAND Safety Introducer with Extended Dwell Catheter;Catalog no. 92006.Used to gain access to the vascular system to sample blood and administer fluids intravenously. Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
GE Healthcare; LLC Sep-18-2013 GE Healthcare; Advantage Workstation; READY View Application – GE Healthcare; Advantage Workstation; READY View Application.Image analysis software. GE Healthcare has become aware that when analyzing fMRI images using the READY View application software; incorrectfMRI activation maps may be computed and displayed.
Kerr/Pentron; DBA Kerr Corporation and Pentron Clinical Sep-19-2013 NX3 Try-In Gel – NX3 Try-In Gel. The product is used as a tooth shade resin material. Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel; because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
Integra LifeSciences Corp. d.b.a. Integra Pain Management Sep-19-2013 Integra¿ Cranial Access Kit – Cranial Access (CRAK) Kits; Product / Catalogue No.s: INSHITH; INSHITHND; INSHITHRZNThe kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP); to monitor CSF; to provide temporary drainage of CSF; and to monitor ICP. Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Laserworld Usa Inc Sep-19-2013 Laserworld – Laserworld RGB & Piko Nano RGB ModelsAll models are laser light show projectors; and will be used as such. It was discovered potentially lack of certification missing laser laser safety warning and administrative labels; potentially incomplete Performance Feature set and incomplete User Information.
GE Healthcare; LLC Sep-19-2013 Seno Advantage medical image review station – GE Healthcare; Seno Advantage; 5183685; 5183685-2; 5183685-3; 5183685-4; 5183685-5; 5183685-6; 5183685-7; 5183685-8; 5183685-9; 5342425; 5342425-2; 5342425-3; 5342425-4; 5342425-5.Seno Advantage is a medical image review station that allows easy selection; processing; filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician; mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. GE Healthcare has recently become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) workstations under certain circumstances. This issue may impact patient safety.
GE Healthcare; LLC Sep-19-2013 CARESCAPE Monitor 650 – GE Healthcare; CARESCAPE Monitor B650.The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult; pediatric; and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of; and to generate alarms for; hemodynamic (including EGG; ST segment; arrhythmia detection; ECU diagnostic analysis and measurement; invasive pressure; non-invasive blood pressure; pulse oximetry; cardiac output; temperature and mixed venous oxygen saturation); impedance respiration; airway gases (C02; 02; N20 and anesthetic agents); spirometry; gas exchange; and neurophysiological (including electroencephalography; Entropy; Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner; or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650.No injuries or illnesses have been reported.
Spine Smith Holdings; LLC Sep-19-2013 VisuALIF – VisuALIF;System consisting of a ‘U’ shaped PEEK block in two footprint configurations; four heights and three lordosis angles.; part number: 0301-1410.Intended to be implanted via an open anterior approach. The product has the potential to be laser marked as a Medium when it actually is a Small.
Steris Corporation Sep-20-2013 Reliance Endoscope Processing System (REPS) – Reliance Endoscope Processing System (REPS); STERIS Corporation; 5960 Heisley Road; Mentor; OH 44060-1834 USA www.steris.com.The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned; immersible; reusable; heat-resistant; semi-critical devices. The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and; as a result; the air pipe does not receive forced flow during the Reliance EPS processing cycle.
Maquet Cardiovascular Us Sales; Llc Sep-20-2013 QUADROX Oxygenator – QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Terumo Cardiovascular Systems Corporation Sep-20-2013 Terumo¿ Pall AL6X Arterial Blood Line Filter – Terumo¿ Pall AL6X Arterial Blood Line Filter; labeled in part ***Terumo Cardiovascular Systems Corporation Elkton; MD 21921***; packaged as part of a Terumo Cardiovascular Procedure Kit or as a single; sterile filter unitSingle/Sterile Terumo¿ Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size; including gas emboli; fat emboli and aggregates composed of platelets; red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo¿ Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours. Medical device used in cardiovascular procedures is defective.
Endoplus; Inc. Sep-21-2013 Endoplus Single Action Insert – ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A; Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd.; Suite A; Mundelein; IL 60060 USA.Intended for grasping; dissecting; retraction; clamping in conjunction with the laparoscopic during laparoscopic surgery. Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Endoplus; Inc. Sep-21-2013 Endoplus 5 mm Traumatic Grasper S/A; Standard – ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A; Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd.; Suite A; Mundelein; IL 60060 USA.Intended for grasping; dissecting; retraction; clamping in conjunction with the laparoscopic during laparoscopic surgery. Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Smiths Medical ASD; Inc. Sep-23-2013 PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems – Smiths Medical; Deltec:REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.REF 21-8052-24 & REF 21-8053-24 ; Port-A-Cath II Dual-Lumen; Polysulfone /Titanium Venous Access System.Sterile EO; Rx Only.PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications; fluids; and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein. Smiths Medical is conducting a voluntary recall of PORT-A-CATH? and PORT-A-CATH? II Implantable Venous and ArterialAccess Systems and Introducer Sets.Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.Smiths Medical has received no reports
Smiths Medical ASD; Inc. Sep-23-2013 PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems – Smith Medical; Deltec; REF 21-2386-24; 11 Fr Introducer Set with Peel-Away Sheath; Sterile EO; Rx OnlyPORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications; fluids; and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein. Smiths Medical is conducting a voluntary recall of PORT-A-CATH? and PORT-A-CATH? II Implantable Venous and ArterialAccess Systems and Introducer Sets.Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.Smiths Medical has received no reports
Invacare Corporation Sep-23-2013 Invacare Power Wheelchair – Invacare Power Wheelchair; one per boxTo provide mobility to a person restricted to a sitting position. Unintended slowing or deceleration; and on rare occasion;unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Microgenics Corp Sep-23-2013 DRI¿ Cocaine Metabolite Assay; Multigent Cocaine Assay – DRI Cocaine Metabolite Assay; labeled as Multigent Cocaine Assay for Abbott Laboratories.100 ml; IVDMfg by:Microgenics Corporation;46360 Fremont Blvd.Fremont; CA 94538The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result. Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate; indicating a faster than expected reagent degradation.
GE Healthcare; LLC Sep-23-2013 Discovery MR750w /MR750; Optima MR450w; Discovery MR450; 1.5/3T Signa HDxt; Signa Vibrant. – GE 1.5T Signa HDxt; 3.0T Signa HDxt; Signa Vibrant; HD23 Software and the following model numbers: 2395001; 2395001-2; 2395001-3; 2395001-4; 5269997-2; 5269997-4; 2377062-61; 5127452-3; 5127452; 5337894-3; 5337894-4; 5911000-4; 5911000-5; 53085735308573-2.GE Discovery MR750w 3.0T; Discovery MR750 3.0T; Optima MR450w 1.5T; Discovery MR450 1.5T.The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution; high signal-to-noise ratio; and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique images; spectroscopic images; parametric maps; and/or spectra; dynamic images of the structures and/or functions of the entire body; including but not limited to head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. Depending on the region of interest being imaged; contrast agents may be used GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products.For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer; the MR Product can generate image headers with non-unique series identifiers; which when exported to some PACS systems; results in the series being associated wit
Stryker Endoscopy Sep-24-2013 Stryker Vision Mounting Arm – Stryker Vision Mounting Arm; for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200; manufactured by Stryker Endoscopy San JoseThe intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001; 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials; as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life. When positioning the display located on top of the video cart; it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
Elekta; Inc. Sep-25-2013 – Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning. Patient needs to be positioned as indicated by the treatment plan.
Elekta; Inc. Sep-25-2013 Monaco RTP System – Monaco RTP SystemRadiation treatment planning Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
Maquet Cardiovascular Us Sales; Llc Sep-25-2013 Maquet – TEGRIS system Four labels of the Tegris System include:Emergency button (1703.72)MAQUET GmbH & Co. KGKehler-Strabe 31Baden-Wuerttemberg76437 Rastatt; Germany Touch screen (elo)Elo TouchSystems 301 Constitution DriveMenlo Park; CA 94025www.elotouch.comManufacturer: Tyco ElectronicsBrand Name: Elo Touch SystemsMade in ChinaTegris system (1703.01)MAQUET GmbH & Co. KGKehler Strabe 3176437 Rastatt; Germany OR Table Module (1703.71)MAQUET GmbH & Co. KGKehler Strabe 31Baden-Wuerttemberg76437 Rastatt; GermanyDesigned to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules;which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights; the main functions of these devices may be separated; e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices; is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710; providing; among other things; protection against electric shock and connections for potential equalization lines. Intended for the following users: medical experts MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.
Synthes USA HQ; Inc. Sep-25-2013 Synthes 3.5 MM LCP(R) Distal Humerus System – Synthes 3.5 MM LCP(R) Distal Humerus SystemThe Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus; olecranon; and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically; distal humerus plates are indicated for intra-articular fractures; comminuted supracondylar fractures; osteotomies; malunions and non-unions of the distal humerus. Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
CareFusion 303; Inc. Sep-26-2013 SmartSite – SmartSite Low Sorbing Infusion Set; Model# 10015048. Intravascular administration set. CareFusion is recalling the SmartSite Low Sorbing Infusion Set; Model# 10015048; because there is a potential for separation at the tubing sleeve below the drip chamber.
CareFusion 303; Inc. Sep-26-2013 CareFusion Gravity Set – CareFusion Gravity Set; Model #44000-07The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient’s artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve; injection ports; 4-way stopcock; anti-siphon valve; roller clamp and tubing. CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled witha 5 year expiration instead of three (3) years.
Becton Dickinson & Company Sep-26-2013 BD Epilor Syringe – BD Epilor SyringeBD Franklin Lakes; NJ 07417BD EDC Laagstraat 57; B-9140 Temse-BelgiumThe Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space. BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.
Medtronic Xomed; Inc. Sep-26-2013 Universal Titanium Prosthesis; – Universal Titanium Prosthesis; Round Head; with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Synthes USA HQ; Inc. Sep-26-2013 Synthes Oracle Spacer System Slap Hammer; Part Number 03.809.690 – Synthes Oracle Spacer System Slap Hammer; Part Number 03.809.690; Lot Number 3723847The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e.; fracture); to achieve anterior decompression of the spinal cord and neural tissues; and to restore the height of the collapsed vertebral body. The Slap Hammer; 03.809.690; is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants. This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
CareFusion 303; Inc. Sep-26-2013 SmartSite Low Sorbing Infusion Set – SmartSite Low Sorbing Infusion Set; Model#72313EThe SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient’s artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter; needleless SmartSite connector; low sorbing tubing segment; pinch clamps; and luer connectors. CareFusion is recalling the SmartSite Low Sorbing Infusion Set; Model 72313E; Lot Number13016314; because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micronfilter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
Stryker Medical Division of Stryker Corporation Sep-26-2013 FL23SE Med-Surg Bed – The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures; therapy; recovery in healthcare environments; and to transport patients between bays and procedural rooms.The FL23SE Bed is intended for use with patients for procedures; therapy; recovery in healthcare environments; and to transport patients between bays and procedural rooms. The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot; the circuit directing the nurse call system can be damaged.
Ebi; Llc Sep-27-2013 Solitaire-35 – Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
GE Healthcare; LLC Sep-27-2013 GE Healthcare; Discovery MR750 3.0T; Optima MR450w 1.5T; and Discovery MR450 1.5T . – GE Healthcare; Discovery MR750 3.0T; Optima MR450w 1.5T; and Discovery MR450 1.5T .scanner designed to support high resolution; high signal-to-noise ratio; and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique images; spectroscopic images; parametric maps; and/or spectra; dynamic images of the structures and organs of the entire body; including but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution; high signal-to-noise ratio; and short scan times. It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique images; spectroscopic images; parametric maps; and/or spectra; dynamic images of the structures and/or functions of the entire body; including but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. Depending on the region of interest being images; contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution; high signal-to-noise ratio; and short scan times. It is indicated for use as a diagnostic imaging device to produce axial; sagittal; coronal; and oblique images spectroscopic images parametric maps; and/or spectra; dynamic images of the structures and/or functions of the entire body; including; but not limited to; head; neck; TMJ; spine; breast; heart; abdomen; pelvis; joints; prostate; blood vessels; and musculoskeletal regions of the body. Depending on the region of interest being imaged; contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450; Discovery MR750; and Optima MR450w products.The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However; any fluid or body substance absorbed
