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SUTUMED
Unilene S.A.C. · Model SDAG010MC360 · UDI-DI 07757093001096
GAN
Prescription
1
510(k) clearances
5,585
Adverse events (8 deaths)
2
Recalls
28
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-08 | ETHICON, INC. | Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
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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.