Recall Z-2145-2024 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
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
| Date | Jun 14, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| Root cause | Under Investigation by firm |
| Action | Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaini |
| Quantity | 55296 units |
| Distribution | Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture ETHICON, Inc., Sep 28, 2018 |