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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SBA11LESLG · UDI-DI 10197106940600
OHD
Prescription
0
510(k) clearances
330
Adverse events
53
Recalls
26
Facilities
Description
BETHLEHEM LEEP PACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac |
| 2026-04-27 | Medline Industries, LP | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o |
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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.