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FOOTPRINT MEDICAL, INC. · Model P1UVC-540 · UDI-DI 00858778006409
FOS
Prescription
1
510(k) clearances
1,545
Adverse events (33 deaths)
7
Recalls
18
Facilities
Description
5.0Fr Single Lumen Polyurethane Umbilical Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2025-05-02 | Cardinal Health 200, LLC | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. |
| 2021-06-16 | Cardinal Health 200, LLC | 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 a |
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Get your free API keyRead the docsData 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.