AVID Medical, Inc.: DAVINCI TRUCUSTOM BUNDLE. 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: 626 units Lot/code info: Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.

UPC codes

10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046

Source

Official record: FDA (Device enforcement) ↗

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