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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SMACGDCAC2 · UDI-DI 10197106237694
PKF
Prescription
0
510(k) clearances
1
Adverse events
2
Recalls
12
Facilities
Description
GYN D C SURGICAL PACK CMC
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-04 | American Contract Systems Inc. | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not |
| 2022-06-16 | American Contract Systems, Inc. | Product was exposed to multiple sterilization cycles without validation for multiple exposures. |
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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.