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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SBA73LCSI5 · UDI-DI 10888439729375
PKE
Prescription
0
510(k) clearances
5
Adverse events
2
Recalls
6
Facilities
Description
LAP CHOLE PACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in |
| 2020-04-13 | American Contract Systems | The surgical gowns were manufactured in a facility that is not registered by the FDA. |
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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.