VICRYL Plus Antibacterial recall: Sterility Concern
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic…
Why was VICRYL 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: 10705031051546 10705031052147 10705031053038 10705031054370 10705031054394 10705031054677 10705031150492 10705031056329 10705031056725 10705031150119 10705031150287 10705031150447 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA
- Product
- VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 55296 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)