Z-2149-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2024
- Initiation Date
- May 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287892 units
Product Description
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: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
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 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.
Code Information
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