AVID Medical, Inc.: GYN LAPAROSCOPY PACK. Medical convenience kit.

Hazard

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Details from the source

Reason for recall: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. Distribution: Domestic: CA, IL, MD, OH, PA, TX, WA. Quantity: 346 units Lot/code info: Model No. NAFB055-08, NAMC436-11, VMCC030-06; UDI: 10809160405185, 10809160417621, 10809160415245, 10809160419021; Kit Lot No. 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, 1608234, 1608349, 1608466, 1613607, 1613139, 1613608, 1616927, 1622475, 1628656, 1632993, 1596145, 1603597, 1608059, 1619856.

UPC codes

10809160405185, 10809160417621, 10809160415245, 10809160419021

Source

Official record: FDA (Device enforcement) ↗

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