AVID Medical, Inc.: GS ENDOSCOPY 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: 816 units Lot/code info: Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.

UPC codes

10809160374597, 10809160417539, 10809160435779

Source

Official record: FDA (Device enforcement) ↗

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