Device product

GYN LAPAROSCOPY PACK. Medical convenience kit.

Z-2250-2025

June 11, 2025

Class II

Product summary

Firm: AVID Medical, Inc.
Event: Event 97149
Status: Ongoing
Classification: Class II
Quantity: 346 units
Official record key: device-enforcement:Z-2250-2025

Official wording

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

Code information: 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.

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.