AVID Medical, Inc.: GENERAL LAPAROSCOPY TRAY. 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: 574 units Lot/code info: Model No. EURO010-08, USAR042-17, WILF006-29; UDI: 10809160414309, 10809160400586, 10809160429914, 10809160431108; Kit Lot No. 1616570, 1581675, 1594938, 1597550, 1600846, 1620149, 1620150, 1620151, 1622920.

UPC codes

10809160414309, 10809160400586, 10809160429914, 10809160431108

Source

Official record: FDA (Device enforcement) ↗

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