Device product
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Z-1320-2014
Product summary
- Event
- Event 67844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15
- Official record key
device-enforcement:Z-1320-2014
Official wording
Reason: The products are labeled as sterile but were not sterilized.
Code information: Lot Number H574228
Distribution pattern: Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Derived failure modes
-
Unknown
The products are labeled as sterile but were not sterilized.