Recall Z-2148-2024 — MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
U.S. FDA — Device Enforcement · United States · 2024-05-10 · Class II
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Reported risk: 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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