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CARDINAL HEALTH
Cardinal Health 200, LLC · Model 12-0940B · UDI-DI 10887488809243
FHQ
Prescription
7
510(k) clearances
1,038
Adverse events
4
Recalls
343
Facilities
Description
STERILE NEEDLE HOLDER KIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-26 | Boss Instruments, Ltd. | The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure. |
| 2020-06-03 | Dufner Instrumente GmbH | Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2009-07-30 | Davol, Inc., Sub. C. R. Bard, Inc. | Product sterility may be compromised due to lack of package integrity. |
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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.