FDA: Getinge recalls Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
Editor's Note The Food and Drug Administration (FDA) on September 30 posted an announcement by Getinge that it is voluntarily initiating a worldwide recall involving a field correction of some 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp. The recall is because of the potential for interruption…
FDA: Pharm D Solutions recalls all sterile compounded drugs
Editor's Note The Food and Drug Administration (FDA) on September 10 posted the announcement by Pharm D Solutions, LLC, (Houston, Texas) that it had voluntarily issued a recall of all sterile compounded drugs because of a potential lack of sterility. The company says concerns about practices at the pharmacy that…
FDA: Class I recall of Arkon Anesthesia Delivery System
Editor's Note The Food & Drug Administration on August 10 identified the recall of Spacelabs Healthcare’s (Snoqualmie, Washington) Arkon Anesthesia Delivery System as Class I, the most serious. The recall was issued because of the system going into a “failed state,” during which the mechanical ventilation function stops working. This…
FDA issues update on wearable cardioverter defibrillator
Editor's Note The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator. The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying…
FDA: Hospira recalls two lots of Naloxone Hydrochloride Injection
Editor's Note The Food & Drug Administration on June 4 announced the recall by Hospira, Inc, of two lots of its opioid antagonist Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69). The two lots, 72680LL and 76510LL, were recalled because…
FDA issues Class I Recall of CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope
Editor's Note The Food & Drug Administration on June 6 identified the recall by Maquet Datascope Corp of its CARDIOSAVE Hybrid Intra-aortic Balloon Pump as Class I, the most serious. The recall was initiated because of a design issue that allows fluid to seep into the device, which can lead…
FDA: New labeling for liquid-filled intragastric balloons
Editor's Note The Food & Drug Administration on June 4 announced that it had approved new labeling on potential risks for liquid-filled intragastric balloons by Apollo Endosurgery and ReShape Lifesciences. The new labeling for the Orbera and ReShape balloon systems includes more information about possible deaths linked to the use…
FDA: Recall of STAT-Check and Medline manual resuscitator bags
Editor's Note The Food & Drug Administration on June 1 announced the recall by SunMed Holdings of 18,808 units of its STAT-Check and Medline manual resuscitator bags. The recall was initiated because the patient port retaining ring of the bags may not fully seat, which could allow the patient port…
FDA: Class I recall of HeartWare HVAD system by Medtronic
Editor's Note The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious. The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power…
FDA: Class I recall of HeartMate 3TM Left Ventricular Assist System
Editor's Note The Food and Drug Administration on May 22 identified the recall by Abbott of all lots of its HeartMate 3TM Left Ventricular Assist System as Class I, the most serious. The recall was issued because of a malfunction in the device’s outflow graft assembly that may cause the…
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