Recall Z-2145-2024— Ethicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ethicon, Inc., initiated 2024-05-10. It names one FDA 510(k) clearance: K181652. Product: VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H. 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
1 on FDA's recordK-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
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
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.