Recall Z-2148-2024— Ethicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ethicon, Inc., initiated 2024-05-10. It names 2 FDA 510(k) clearances: K964072, K960653. Product: 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. Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection ..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-10
- Firm location
- Raritan, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
- K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Data sourced from openFDA. This site is unofficial and independent of the FDA.