Device product
BIOPHEN UFH Control C2, REF 223901
Z-1188-2019
Product summary
- Event
- Event 82468
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14 kits
- Official record key
device-enforcement:Z-1188-2019
Official wording
Reason: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Code information: Lot F1700315P7
Distribution pattern: Distributed to accounts in MI and PA.
Derived failure modes
-
Unknown
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.