FDA Enforcement
Class II
Terminated
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
Recall: Z-1354-2021
·
Reported April 14, 2021
Enforcement
- Recall Number
- Z-1354-2021
- Event ID
- 87596
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 14, 2021
- Initiation Date
- March 17, 2021
- Classification Date
- April 5, 2021
- Termination Date
- December 2, 2021
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
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
Reason
Incorrect labeling, Catheter did not have the required holes and markings
Code Info
Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205
Distribution
CA CO FL KY MD NC NC NY NY TX WI
Quantity
49 units