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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SANMHVAMHA · UDI-DI 10887488652016
OWL
Prescription
0
510(k) clearances
82
Adverse events
16
Recalls
36
Facilities
Description
STERILE ULTRASOUND GUIDED PIV
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2026-03-11 | ARROW INTERNATIONAL, LLC | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured |
| 2025-12-22 | LSL Healthcare Inc. | BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| 2022-10-12 | Medical Action Industries, Inc. 306 | The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits. |
| 2020-06-15 | Access Scientific LLC | Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user d |
| 2018-02-28 | Vygon U.S.A. | Potential friction holes may affect the sterility of the product. |
| 2018-02-28 | Vygon U.S.A. | Potential friction holes may affect the sterility of the product. |
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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.