Vicryl recall: Sterility Concern
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not…
Why was Vicryl 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?
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
- Product
- VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 341532 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)