Monocryl recall: Sterility Concern
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated…
Why was Monocryl 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: GTIN 10705031058729 10705031058897 10705031059047 10705031059092 10705031059122 30705031059133 10705031112674 10705031059146 10705031059153 10705031059245 10705031059894 10705031059917 10705031059962 PRODUCT CODE PRODUCT LOTS Y315H UAMQCX Y345H UBMCAJ Y359H UBMHQS Y398H UAMLMU UAMPJB UAMMXQ UBMJPB UBMQQR Y416H UAMLQM UAMLKM UAMRMZ Y417H UCMEDU Y426H UAMKCL UAMKHE UAMPQS UBMJTE Y427H UAMLXX UAMMJR UAMPSC Y935H UBMCAA UBMDKJ UBMDKC UBMHDD Y936H UBMJQM Y945H UAMKCD
- Product
- MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 306000 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)