# FDA recall Z-1354-2021

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2021-03-17.

## 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

## Distribution

CA  CO  FL  KY  MD  NC  NC  NY  NY  TX  WI

## Key facts

- **Recall number:** Z-1354-2021
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-17
- **Report date:** 2021-04-14
- **Termination date:** 2021-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1354-2021

## Citation

> AI Analytics. FDA recall Z-1354-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1354-2021. Source: US FDA. Licensed CC0.

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