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Catheter, Umbilical Artery

FDA product code FOS · Class 2 · General Hospital

98
Registered devices
1,545
Adverse events
7
Recalls
34
510(k) clearances

Devices with this code

Recent 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 fea

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.