# FDA recall Z-2138-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-05-07.

## Product

CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.  Product Number: 821750

## Reason for recall

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

## Distribution

Worldwide - US Nationwide distribution in the state of TX and the countries of Canada,  China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey

## Key facts

- **Recall number:** Z-2138-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-07
- **Report date:** 2024-06-19

- **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-2138-2024

## Citation

> AI Analytics. FDA recall Z-2138-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2138-2024. Source: US FDA. Licensed CC0.

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