FDA: Hospira recalls one lot of Bacteriostatic Water for Injection
Editor's Note The Food & Drug Administration on September 6 posted Hospira, Inc’s recall of one lot of Bacteriostatic Water for Injection, USP, 30 mL, multi-dose vials, lot W20308. The recall was initiated because of the potential for a lack of sterility assurance. To date, Hospira has not received any…
FDA: Class I recall of Vyaire Medical enFlow fluid warming disposable cartridge
Editor's Note The Food & Drug Administration (FDA) on August 21 identified Medline Industries’ recall of Centurion Medical Products’ Primary Warmer Pack containing the Vyaire Medical enFlow fluid warming system disposable cartridge as Class I, the most serious. The recall was initiated because the cartridge may elute aluminum into infused…
FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System
Editor's Note The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System. The recall was initiated…
FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library
Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…
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…
Free Daily News
- Hospital addresses barriers to patient rest, recovery
- Study: Psilocybin therapy reduces depression in frontline clinicians
- Exclusive articles preview OR Business Management Conference sessions
- Study: Surgeries improve survival in young BRCA-positive breast cancer patients
- Study: Advanced recovery room care could reduce long-term postoperative mortality
- FDA designates Class 1 recalls for balloon catheters, radiographic markers
- Orthopedic surgery in 2025: Embracing innovation, preserving autonomy
- Medtronic, Zimmer Biomet challenge Intuitive Surgical’s robotic surgery dominance
- Anthem’s anesthesia time limit policy, reversal sparks new legislation
- Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion