FDA Device recall Z-1354-2021
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking by Integra Lifesciences, citing incorrect labeling, Catheter did not have the required holes and markings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1354-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-17 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Integra Lifesciences |
| Distribution | CA, CO, FL, KY, MD, NC, NY, TX, WI |
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
Reason
Incorrect labeling, Catheter did not have the required holes and markings
Identifiers
| code_info | Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1354-2021%22
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