Device product
GS ENDOSCOPY PACK. Medical convenience kit.
Z-2249-2025
Product summary
- Event
- Event 97149
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 816 units
- Official record key
device-enforcement:Z-2249-2025
Official wording
Reason: CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Code information: 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.
Distribution pattern: Domestic: CA, IL, MD, OH, PA, TX, WA.
Derived failure modes
-
Unknown
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.