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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SMAOCGOHHA · UDI-DI 10887488465531
OHD
Prescription
0
510(k) clearances
403
Adverse events
56
Recalls
26
Facilities
Description
STERILE GYN OPEN PACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Medline Industries, LP | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result |
| 2026-08-18 | Cardinal Health 200, LLC | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl |
| 2026-07-29 | Cardinal Health 200, LLC | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is |
| 2026-07-10 | Medline Industries, LP | Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
| 2026-06-08 | Medline Industries, LP | Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter |
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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.