FDA: Class I recall of Atrium Medical’s iCast Covered Stent
Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…
FDA: Class I recall of Arjo Sara Plus lift
Editor's Note The Food and Drug Administration (FDA) on May 27 identified the recall of the ArjoHuntleigh Polska Sara Plus floor lift as Class I, the most serious. The recall was initiated because of the risk of smoke or fire if the lift is used when the battery is low.…
FDA: Class I recall of Abbott’s Dragonfly OpStar Imaging Catheter
Editor's Note The Food and Drug Administration (FDA) on May 26 identified the recall of Abbott Medical’s Dragonfly OpStar Imaging Catheter as Class I, the most serious. Abbott is recalling certain lots of the imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose…
ECRI: 2022 winners of Alerts Impact Award
Editor's Note ECRI on May 25 announced the three winners and three finalists of its 2022 Alerts Impact Award for excellence in recall management. The annual award is given to those who have demonstrated strong success in implementing recall management programs in their healthcare organizations. The winners are: Eskenazi Health,…
FDA: Class I recall of Woodside Acquisitions SARS-CoV-2 antigen rapid test kits
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall of Woodside Acquisitions Inc’s Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) as Class I, the most serious. The tests are being recalled because they were distributed to…
NIOSH rescinds approval for Pacific PPE N95 respirator masks
Editor's Note The National Institute for Occupational Safety and Health (NIOSH) announced on March 28 that it had honored a request by Pacific PPE Corp to rescind all of its N95 respirator mask approvals, effective immediately. Respirators with NIOSH approval numbers TC-84A-9278, TC-84A-9299, and TC-84A-9313 will no longer be manufactured,…
FDA: Class I recall of certain Celltrion USA COVID-19 test kits labeled for research use only
Editor's Note The Food and Drug Administration (FDA), on March 23, identified the recall by Celltrion USA of certain point of care DiaTrust COVID-19 Ag Rapid Test kits (labeled for research use only) as Class I, the most serious. The recall was initiated because the kits were distributed to customers…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
Editor's Note The Food and Drug Administration (FDA) on March 21 identified the recall by Philips Respironics of certain V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because a subset of these devices had parts that were put together using an expired adhesive.…
FDA: Fresenius Kabi recalls Sodium Acetate Injection, USP, 400 mEq/100 mL
Editor's Note The Food and Drug Administration on March 7 posted the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of seven lots of its Sodium Acetate Injection, USP, 400 mEq/100 mL The recall was initiated because of the presence of particulate matter found in reserve and/or stability sample vials.…
FDA: Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System
Editor's Note The Food and Drug Administration, on March 9, identified the recall by Medtronic of its TurboHawk Plus Directional Aherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire in the catheter moving downward or prolapsing when force is applied…
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