MONOCRYL Plus Antibacterial recall: Sterility Concern
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable…
Why was MONOCRYL Plus Antibacterial recalled?
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 287892 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.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)