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HomeCardinal Health, Inc. › Argyle

Argyle

Cardinal Health, Inc. · Model 8888160408 · UDI-DI 10884527005147

FOS Prescription
10
510(k) clearances
1,545
Adverse events (33 deaths)
7
Recalls
18
Facilities

Description

Umbilical Vessel Catheter Tray,No Catheter

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.