Editor's Note An ongoing US Food and Drug Administration (FDA) evaluation of plastic syringes made in China reveals that quality problems are more widespread than initially believed, the agency reported on March 19. The update to an original November 23 safety notice recommends the following action to alleviate potential quality…
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…
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…
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…
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…
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,…
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…
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…
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…
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…