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SURGISTAR
SURGISTAR, INC. · Model 2300 · UDI-DI 00878799005281
10
510(k) clearances
127
Adverse events
6
Recalls
164
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-06 | Southmedic, Inc. | Scalpels lot contains non-sterile products labeled as sterile. |
| 2015-08-18 | Zien Medical Technologies, Inc | Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause anal |
| 2013-02-07 | Myco Medical Supplies Inc | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
| 2010-09-03 | Southmedic, Inc. | Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. |
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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.