Ethicon, Inc.: PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. Thes

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: 56952 units Lot/code info: GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

UPC codes

10705031026216, 10705031060166, 10705031060289, 10705031060395, 10705031060517

Source

Official record: FDA (Device enforcement) ↗

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