Device product

LAP CHOLE PACK. Medical convenience kit.

Z-2253-2025

June 11, 2025

Class II

Product summary

Firm: AVID Medical, Inc.
Event: Event 97149
Status: Ongoing
Classification: Class II
Quantity: 85 units
Official record key: device-enforcement:Z-2253-2025

Official wording

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

Code information: Model No. VCIH007-06; UDI: 10809160379479, 10809160450758; Kit Lot No. 1569227, 1569228, 1569229, 1589126, 1608615, 1623944, 1643426.

Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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