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…
Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
FDA issues warning letters to endoscope manufacturer
Editor's Note The Food and Drug Administration (FDA) on January 10 announced that it had recently issued two warning letters to Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd, after facility inspections. The letters addressed violations related to medical device reporting (MDR) requirements and quality…
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: 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 Dewei Medical Equipment’s DNA/RNA Preservation Kits
Editor's Note The Food and Drug Administration (FDA) on December 8 identified the recall by Dewei Medical Equipment Co of its DNA/RNA Preservation Kits as Class I, the most serious. The kits are used to collect, preserve, and transport clinical samples that will be tested for viruses, including COVID-19. The…
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,…
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