Integra Cranial Access Kit — Class II medical device recall Z-0551-2014
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2014-01-01, distributed nationwide. Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identi
| Recall number | Z-0551-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2013-11-26 |
| Classified | 2013-12-20 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2014-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 731 |
| Reason classes | labeling |
| Lot numbers | W1302120, W1305038, W1306137 |
| Model numbers | HITHSP10 |
| Expiration dates | 2014-02-01, 2014-09-01, 2015-08-01 |
Product
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.
Reason for recall
Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.
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-0551-2014. 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.