Device product
CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188
Z-2472-2019
Product summary
- Event
- Event 83478
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3820 units
- Official record key
device-enforcement:Z-2472-2019
Official wording
Reason: The filter capacity is not achieved due to damage of the filter membrane.
Code information: Lot # 0061537846 Exp: 8/31/2018 Lot # 0061537847 Exp: 10/31/2018 Lot # 0061620282 Exp: 9/30/2019 UDI: 04046964941436
Distribution pattern: CA FL MO TX MN AL GA NC IL PA
Derived failure modes
-
Unknown
The filter capacity is not achieved due to damage of the filter membrane.