CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe… — Class II medical device recall Z-1354-2021
Terminated recall by Integra LifeSciences Corp., reported 2021-04-14, distributed in CA, CO, FL, KY, MD, NC, NY, TX…. Incorrect labeling, Catheter did not have the required holes and markings
| Recall number | Z-1354-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2021-03-17 |
| Classified | 2021-04-05 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2021-12-02 |
| Distributed | CA, CO, FL, KY, MD, NC, NY, TX, WI |
| Quantity | 49 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10381780526797 |
| Lot numbers | 5028205 |
| Model numbers | NS5524 |
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 for recall
Incorrect labeling, Catheter did not have the required holes and markings
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1354-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.