The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Reason for recall: The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. Distribution: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy; Quantity: 2448 units Lot/code info: 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
10884521126732, 20884521126739, 10884521126787, 20884521126784
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.