FDA: Class I recall of Teleflex/Sheridan Endotracheal Tubes
Editor's Note The Food & Drug Administration (FDA) on August 2 identified the recall by Centurion Medical Products of its Airway Kit containing Teleflex/Sheridan Endotracheal Tubes as Class I, the most serious. The recall was initiated because of the potential for the tube connector to dislodge from the endotracheal tube,…
NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes
Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…
FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators
Editor's Note The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious. The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process…
FDA: Class I recall of Getinge’s Maquet/Datascope intra-aortic balloon pumps
Editor's Note The Food & Drug Administration on July 23 identified the recall by Getinge of its Maquet/Datascope intra-aortic balloon pumps (IABPs) as Class I, the most serious. Recall of the Cardiosave Hybrid, Cardiosave Rescue, CS300, and CS 100/100i IABPs was initiated because of reports of the IABP batteries failing…
FDA: Class I recall of Alaris Infusion Sets
Editor's Note The Food & Drug Administration (FDA) on July 18 identified the recall by Becton Dickinson of its Alaris Infusion Sets for the Alaris Pump Model 8100 as Class I, the most serious. The recall was initiated because of the potential for tube collapse that may cause unintended or…
FDA: Class I recall of Neonatal ConchaSmart Breathing Circuit
Editor's Note The Food & Drug Administration (FDA) on July 17 identified the recall by Teleflex of its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column as Class I, the most serious. The recall was initiated because of complaints of cracks in the swivel wye adaptors, which…
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…
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