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 updates recommendations to reduce surgical fires
Editor's Note The Food & Drug Administration (FDA) on June 5 updated its Safety Communication: “Recommendations to Reduce Surgical Fires and Related Patient Injury.” Among the recommendations: Perform a fire risk assessment before each surgical procedure. Encourage communication among anesthesia personnel, surgeons, and OR staff. Practice safe use and administration…
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…
ECRI Institute research helped guide FDA report on medical device servicing
Editor's Note The ECRI Institute on May 21 announced that it had provided conclusive research to help guide the Food and Drug Administration’s (FDA) new “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.” The FDA report, which addresses concerns about the quality of service provided…
FDA: Class I recall of Medtronic’s MindFrame Capture LP revascularization device
Editor's Note The Food and Drug Administration (FDA) on May 18 identified the recall of Medtronic’s MindFrame Capture LP revascularization device as Class I, the most serious. Medtronic is recalling the device because there is a risk of the delivery wire breaking or separating during use. The clot retriever, which…
FDA: Class I recall of Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit
Editor's Note The Food and Drug Administration (FDA) on May 11 announced the Class I recall, the most serious, of Vyaire Medical Inc's (Lake Forest, Illinois) AirLife Resuscitation Device & Broselow Convenience Kit. The recall was initiated because of an error in product design that may result in difficulty or…
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