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MONOCRYL
ETHICON, LLC · Model Y947H · UDI-DI 10705031059986
GAN
Prescription
1
510(k) clearances
5,585
Adverse events (8 deaths)
2
Recalls
28
Facilities
Description
Undyed Monofilament (Poliglecaprone 25), Absorbable Surgical Suture
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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