Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient.
Recalls
FDA puts highest-risk category on Symbios infusion pump recall
Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose.
The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.
FDA blames poor training for new deaths, injuries tied to Stryker’s recalled Neptune systems
J&J faces 2nd trial in in recalled hip controversy | MassDevice.com On Call
MASSDEVICE ON CALL — Healthcare giant Johnson & Johnson (NYSE:JNJ) denied claims this month in the 2nd of tens of thousands of patient injury lawsuits over its implanted metal-on-metal hips.
FLASH: Jury deems J&J’s DePuy ASR XL hip implant defective in design, orders $8.3M in damages
A California jury ruled against Johnson & Johnson (NYSE:JNJ) and its DePuy subsidiary in finding that the company’s ASR XL metal-on-metal hip implant was defectively designed.
Ad-Tech brain implant recall gets FDA’s highest-risk status | MassDevice.com On Call
MASSDEVICE ON CALL — Federal healthcare regulators gave Ad-Tech Medical Instrument Corp.’s wide-reaching brain implant recall Class I status, the highest-risk category for medical device recalls.
Late last year the Wisconsin-based medical device maker recalled its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.
Neuro devices maker recalls implanted electrodes over brain damage concerns
Wisconsin-based medical device maker Ad-Tech Medical Instrument Corp. launched a wide-reaching recall of its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.
The recall extends to devices manufactured from June 2006 to March 2012, according to an FDA notice.
Medical device recalls for February 2013
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
GE Healthcare; LLC Feb-08-2013 Giraffe and Panda Bag and Mask Resuscitation System – Giraffe and Panda Bag and Mask Resuscitation SystemThe T-piece Resuscitation System [ventilator; emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Study: 1 in 10 recalled St. Jude Medical Riata lead coatings fail within 6 years
Danish researchers reported this week that their latest studies of St. Jude Medical‘s (NYSE:STJ) recalled Riata defibrillator leads found that 1 in 10 had poked through their coating in an average of just over 5 years.
FDA issues draft guidance on distinguishing medical device recalls from product enhancements
The FDA issued draft guidance for medical device companies on distinguishing between a recall and a product enhancement that doesn’t need 1, saying it recognizes that "continuous improvement activities" "often have a favorable impact on medical device safety and are part of ongoing efforts to design and manufacture devices that meet the needs of the user and patient."
The aim is to help companies figure out when a recall is warranted, according to the federal watchdog agency.
FDA slaps Lumenis recall with Class I status
The FDA slapped the recall of the Lumenis VersaCut tissue morcellator with Class I status, denoting a device that can cause serious injury or death.
Morcellators are used to cut and remove large masses of tissue during laparoscopic procedures. Yokneam, Israel-based Lumenis is pulling the devices due to a labeling problem that could lead to "serious adverse health consequences, including death," according to the FDA.