# FDA recall Z-1873-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-04-17.

## Product

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure.  Catalog Number: INS5HND

## Reason for recall

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

## Distribution

Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

## Key facts

- **Recall number:** Z-1873-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-17
- **Report date:** 2024-05-29

- **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-1873-2024

## Citation

> AI Analytics. FDA recall Z-1873-2024. Retrieved 2026-09-12 from https://api.ai-analytics.org/recall/Z-1873-2024. Source: US FDA. Licensed CC0.

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