FDA Device recall Z-2144-2024
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surge…
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surge… by Ethicon, citing issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2144-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-10 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | US |
Product
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
Reason
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Identifiers
| code_info | UDI-DI: N/A PRODUCT CODE PRODUCT LOTS J214H UAMPJQ J218H UBMJSK J…UDI-DI: N/A PRODUCT CODE PRODUCT LOTS J214H UAMPJQ J218H UBMJSK J258H UBMHSJ J268H UBMLPP J269H UAMMAH UAMRMU J327H UAMPEP J344H UBMHRU J345H UAMJPK UAMPKD J370H UAMMJT J416H UAMRSJ UAMRHB J417H UAMLMX J426H UAMQRQ UBMCAC UBMCML UBMCRD J427H UAMRPR J458H UAMQRT J493H UAMMKE J603H TPMBSX UAMLXC UAMMBQ J699H UAMQME J936H UAMMSL J978H UAMKBD UAMHTE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2144-2024%22
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