Z-1354-2021 Class II Terminated
FDA device recall Z-1354-2021 was initiated by Integra LifeSciences Corp. on March 17, 2021 and is designated Class II. Reason for recall: Incorrect labeling, Catheter did not have the required holes and markings The recall status is terminated (terminated December 2, 2021). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- December 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product 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 for Recall
Incorrect labeling, Catheter did not have the required holes and markings
Distribution Pattern
CA CO FL KY MD NC NC NY NY TX WI
Code Information
Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205