Device product
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
Z-1354-2021
Product summary
- Event
- Event 87596
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-1354-2021
Official wording
Reason: Incorrect labeling, Catheter did not have the required holes and markings
Code information: Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205
Distribution pattern: CA CO FL KY MD NC NC NY NY TX WI
Derived failure modes
-
Labeling or packaging
Incorrect labeling