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McKesson
MCKESSON MEDICAL-SURGICAL INC. · Model 20-1080N · UDI-DI 00612479211438
10
510(k) clearances
770
Adverse events (2 deaths)
44
Recalls
133
Facilities
Description
GLOVE, SURG STR LTX PF SZ8
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection |
| 2023-08-03 | Ansell Healthcare Products LLC | Some surgical glove sterile pouches were not completely sealed. |
| 2023-08-03 | Ansell Healthcare Products LLC | Some surgical glove sterile pouches were not completely sealed. |
| 2022-03-15 | Cardinal Health 200, LLC | Product was distributed without being sterilized. |
| 2022-02-19 | Ansell Healthcare Products LLC | Transport company failed to stop at the border for required FDA inspection. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| 2020-07-29 | Cardinal Health 200, LLC | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
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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.