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Key Surgical Needle Counters
KEY SURGICAL, INC. · Model NC-30-121B · UDI-DI 00849771031147
8
510(k) clearances
560
Adverse events
7
Recalls
123
Facilities
Description
Needle Counters, Sterile, 30 Count, Dual Magnetic, Solid Lid, Blade Remover, 50 per box
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2018-04-24 | Medline Industries Inc | The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needl |
| 2011-03-10 | Biomet, Inc. | The firm initiated a recall due to the discovery that the devices were not sterilized, as required, prior to distribution. |
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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.