Ethicon, Inc.: MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y39

Hazard

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Details from the source

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: 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. Quantity: 306000 units Lot/code info: 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

UPC codes

10705031058729, 10705031058897, 10705031059047, 10705031059092, 10705031059122, 30705031059133, 10705031112674, 10705031059146, 10705031059153, 10705031059245, 10705031059894, 10705031059917, 10705031059962

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.