Device product
BIOPHEN LMWH Control C4, REF 224201
Z-1190-2019
Product summary
- Event
- Event 82468
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1190-2019
Official wording
Reason: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Code information: Lots F1701555P4
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.