Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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: 55296 units Lot/code info: 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
10705031051546, 10705031052147, 10705031053038, 10705031054370, 10705031054394, 10705031054677, 10705031150492, 10705031056329, 10705031056725, 10705031150119, 10705031150287, 10705031150447
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.