Device 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
Z-2144-2024
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 94643
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 341532 units
- Official record key
device-enforcement:Z-2144-2024
Official wording
Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
sterility compromised