Ethicon, Inc.: MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: M

Hazard

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Details from the source

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 . 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. Quantity: 287892 units Lot/code info: GTIN: 10705031046337 10705031121393 10705031121423 10705031121430 10705031046405 10705031046429 10705031046481 10705031046498 10705031046504 10705031046511 10705031121997 10705031148116 10705031122000 10705031122314 10705031122338 10705031046634 10705031046757 10705031046795 10705031046863 Product Code Lot Code MCP266H UAMMCX MCP340H UAMQUZ MCP416H UBMHLB MCP417H UBMLKK MCP426H UAMLDQ UAMRSL UAMRUM UAMRUU UAMRMR UAMRUK UAMRMB MCP427H UAMLRK UAMMCH UAMLTR UAMKTS UAMKQL UAMREE MCP604H UAMLQE MCP936H UBMDQM UBMDPZ UBMEXS UBMQAR UBMEQX UBMKZA UBMLDR MCP945H UAMRKQ MCPB346H UAMQZB

UPC codes

10705031046337, 10705031121393, 10705031121423, 10705031121430, 10705031046405, 10705031046429, 10705031046481, 10705031046498, 10705031046504, 10705031046511, 10705031121997, 10705031148116, 10705031122000, 10705031122314, 10705031122338, 10705031046634, 10705031046757, 10705031046795, 10705031046863

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.