# FDA recall Z-0818-2022

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2022-01-21.

## Product

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures.  Part Number: 826616

## Reason for recall

Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

## Distribution

Worldwide distribution - US Nationwide and the country of Hong Kong.

## Key facts

- **Recall number:** Z-0818-2022
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-21
- **Report date:** 2022-03-30
- **Termination date:** 2024-03-19

- **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-0818-2022

## Citation

> AI Analytics. FDA recall Z-0818-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0818-2022. Source: US FDA. Licensed CC0.

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