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,…
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…
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…
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…
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…
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…
FDA: Exela Pharma Sciences, LLC, expands recall of Sodium Bicarb
Editor's Note The Food and Drug Administration (FDA) on November 29 posted Exela Pharma Sciences’ expansion of its recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The product poses a safety concern because of vial breakage with flying glass when pressurized while preparing the product for…
FDA: Class I recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate
Editor's Note The Food and Drug Administration (FDA) on December 9 identified the recall by Remel, Inc, of its Thermo Scientific Gram Negative IVD AST Sensititre Plate as Class I, the most serious. The Plates are used to test the susceptibility of Gram-negative bacterial infections to specific antibiotics. The recall…
FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk
Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…
FDA: Class I recall of Teleflex Iso-Gard Filter S
Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…
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