Tag: Product Recalls

Session: Imminent supply chain disruptors—What's your business continuity plan?

Editor's Note “Can cost and resiliency co-exist?” Michael Schiller, CMRP, executive director (interim) of the Association for Healthcare Resources and Materials Management—a professional membership group of the American Hospital Association—asked this session’s audience on the last day of the OR Business Management Conference. “They can co-exist,” he said, “but resiliency…

Read More

By: Tarsilla Moura
February 8, 2024
Share

Burns prompt recalls of airway scopes, electrosurgical pads

Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…

Read More

By: Brita Belli
December 21, 2023
Share

FDA: Class I recall of Ivenix Infusion System

Editor's Note The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious. The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area…

Read More

By: Judy Mathias
April 19, 2023
Share

FDA: Class I recall of Abbott’s glucose monitoring systems

Editor's Note The Food and Drug Administration (FDA), on April 6, identified the recall by Abbott of its FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems as Class I, the most serious. The recall was initiated because the systems’ reader devices, which use rechargeable…

Read More

By: Judy Mathias
April 11, 2023
Share

FDA: Class I recall of Skippack Medical Lab COVID-19 tests

Editor's Note The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance,…

Read More

By: Judy Mathias
February 14, 2023
Share

FDA: Class I recall of Smiths Medical CADD Infusion System Administration Sets, Cassette Reservoirs

Editor's Note The Food and Drug Administration (FDA) on February 2 identified the recall by Smiths Medical of certain CADDTM Infusion System Administration Sets and Cassette Reservoirs as Class I, the most serious. The recall was initiated because of tubing occlusion and false “no disposable attached” alarm issues, which may…

Read More

By: Judy Mathias
February 10, 2023
Share

FDA: Class I recall of Medtronic Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters

Editor's Note The Food and Drug Administration (FDA) on January 30 identified the recall by Medtronic of its Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar QPlus) as Class I, the most serious. The recall was initiated because of a potential catheter hub defect that may cause…

Read More

By: Judy Mathias
February 1, 2023
Share

FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller

Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…

Read More

By: Judy Mathias
January 30, 2023
Share

FDA: Class I recall of Arrow central venous access and catheter kits

Editor's Note The Food and Drug Administration (FDA) on December 16 identified the recall by Teleflex and Arrow International, LLC, of its Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits as Class I, the most serious. The recall…

Read More

By: Judy Mathias
January 4, 2023
Share

FDA: Class I recall of Arrow AutoCAT2, AC3 IABPs

Editor's Note The Food and Drug Administration (FDA), on December 20, identified the recall by Arrow International, LLC, subsidiary of Teleflex, Inc, of its Arrow AutoCAT 2 and AC3 intra-aortic balloon pumps (IABPs) as Class I, the most serious. IABPs are used in patients having cardiac and non-cardiac surgery, and…

Read More

By: Judy Mathias
January 3, 2023
Share

Join our community

Learn More
Video Spotlight
Live chat by BoldChat