FDA: Class I recall of Hamilton–G5 Ventilators
Editor's Note The Food & Drug Administration on July 12 identified the recall by Hamilton Medical AG (Bonaduz, Switzerland) of its Hamilton-G5 Ventilators as Class I, the most serious. The recall was initiated because of a software failure that stops the ventilators after displaying an error message, leaving patients to…
FDA: Class I recall of Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Device
Editor's Note The Food and Drug Administration on July 1 identified the recall by Edwards Lifesciences (Irvine, California) of its IntraClude Intra-Aortic Occlusion Device as Class I, the most serious. The recall was initiated because of a risk of balloon rupture during use in patients undergoing cardiopulmonary bypass. The company…
FDA: Class I recall of Hudson RCI Sheridan, Sheridan Endotracheal Tubes
Editor's Note The Food & Drug Administration on June 21 identified the recall by Teleflex Medical (Wayne, Pennsylvania) of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the risk of the Sheridan connector disconnecting from the breathing circuit.…
FDA: Class I recall of Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter
Editor's Note The Food & Drug Administration on June 18 identified the recall by Cook Incorporated (Bloomington, Indiana) of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6 mm x 4 cm as Class I, the most serious. The recall was initiated because of multiple complaints of balloons bursting below…
FDA panel recommends reclassification of surgical staplers to Class II
Editor's Note The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices. The Committee said Class II regulation would offer a…
FDA: Class I recall of SOLOPATH Balloon Expandable TransFemoral System, Re-Collapsible Balloon Access System
Editor's Note The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious. The recall was initiated because the tip could dislodge from the outer…
FDA: Heritage Pharmaceuticals recalls Amikacin Sufate Injection, Prochlorperazine Edisylate Injection
Editor's Note The Food & Drug Administration (FDA) on May 28 announced the recall by Heritage Pharmaceuticals Inc (East Brunswick, New Jersey) of Amikacin Sulfate Injection, USP 1 gm/4 mL (250 mg/mL), Lot: VEAC025, Expiry Date: October 2019; and Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL), Lot: VPCA172,…
FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems
Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…
FDA: Class I recall of Ethicon circular staplers
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…
FDA issues alert on premature battery depletion in certain Medtronic pacemakers
Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…
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