Haemonetics warns blood bank to check potential leak defects
Haemonetics (NYSE:HAE) sent a letter to its customers warning of potential leak defects in its blood collecting equipment, specifically in plastic Y-connectors.
The company said the health risk is minimal and there have been no reports of "adverse events" so far.
The Braintree, Mass.-based blood management company late November was at the heart of a blood quarantine in Quebec. The company instructed health officials to discard suspicious equipment, but there was ultimately no contaminated blood found.
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Natus cooling system gets Class I status from FDA
The FDA slapped Seattle, Wash.-based company Natus Medical (NSDQ:BABY) with Class I recall status over its Olympic Cool Cap systems.
The Olympic Cool Cap, which received FDA approval in 2006, is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy in full-term infants.
The Cool-Caps’ Control Module may experience a frozen screen during treatment, becoming unable to provide cooling treatment to the infants, the FDA noted.
Natus is notifying all customers to instruct them on how to recognize a screen freeze condition and how to recover from it. The company will continue selling the device, according to the press release.
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FDA slaps Verathon reusable blades with Class I status
A recall of Verathon’s Certain GlideScope Video Laryngoscope reusable blades received Class I status from FDA.
The device is designed to provide a "consistently clear, real-time view of the patient’s airway, enabling quick intubation," according to the company’s website.
Washington medical device maker Verathon earlier this month recalled its GlideScope GVL video laryngoscope blades after finding that they might be prone to cracks and breaks that may leave pieces in a patients mouth where they may be swallowed or block the airway.
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Ethicon Surgiflo hemostatic matrix receives Class I recall status from FDA
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s Surgiflo hemostatic matrix and Surgiflo hemostatic matrix kit plus flex tip with Thrombin
received Class I recall status from FDA.
The device, which helps stop the flow of bleeding in surgical procedures, was pulled off of shelves over potential packaging issues that could lead to device contamination.
Cuts in the device packing process could potentially breach the double Tyvek pouch of the packaging and may cause serious adverse health consequences, including death, FDA noted.
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