Codman Cranial Access Kits- indicated when a craniotomy is required… — Class II medical device recall Z-0817-2022
Terminated recall by Integra LifeSciences Corp., reported 2022-03-30, distributed nationwide. Incorrect extended expiration dates identified on the outer box label only, if product is used past the correc
| Recall number | Z-0817-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2022-01-21 |
| Classified | 2022-03-22 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2024-03-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 1,161 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10381780520375 |
| Lot numbers | 20LDC222, 21HDC461 |
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. Product umber: 826614
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0817-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.