# FDA recall Z-1195-2024

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2024-01-19.

## Product

Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

## Reason for recall

A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

## Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium,  Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia,  South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).

## Key facts

- **Recall number:** Z-1195-2024
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-19
- **Report date:** 2024-03-06

- **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-1195-2024

## Citation

> AI Analytics. FDA recall Z-1195-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1195-2024. Source: US FDA. Licensed CC0.

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