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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SANRPPFBA1 · UDI-DI 10197106911884
OIP
Prescription
0
510(k) clearances
4
Adverse events
5
Recalls
19
Facilities
Description
IR PACK FLINT
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 |
| 2023-08-16 | Cardinal Health 200, LLC | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). |
| 2022-03-22 | American Contract Systems, Inc. | Product was sterilized with a higher than specification EO concentration. |
| 2021-08-10 | ROi CPS LLC | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. |
| 2021-08-10 | ROi CPS LLC | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. |
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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.