FDAJune 16, 2021device
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
What to do
FDA enforcement status: Terminated
Brands named
cardinal health 200cardinalcardinal health
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAPrimidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-112026-05-01
- FDAPrimidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-112026-05-01
- FDAVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-082026-05-01
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
- FDAAtomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-012026-04-30
- FDAOptase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.2026-04-20
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