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Argyle

Cardinal Health 200, LLC · Model 8888160648 · UDI-DI 10192253040371

FOS Prescription
10
510(k) clearances
1,556
Adverse events (34 deaths)
7
Recalls
18
Facilities

Description

Argyle Polyurethane Umbilical Vessel Catheter Triple Lumen 5 Fr/Ch (1.7 mm) x 9-8/10"" (25 cm) 18/21/21 G (1.3/0.8/0.8 mm) 0.32 mL, 0.19 mL, 0.19 mL"

Recalls

DateFirmReason
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2025-05-02Cardinal Health 200, LLCPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
2021-06-16Cardinal Health 200, LLCThe 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 a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.