FDA Device recall Z-0551-2014
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of Integra Cranial Access Kit, Model Number HITHSP10, Rx Only by Integra Lifesciences D B A Integra Pain Management, citing integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-26 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences D B A Integra Pain Management |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Integra Lifesciences D B A Integra Pain Management
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FDA Device · Class II · 2016-09-28 · Integra Lifesciences D B A Integra Pain Management - Integra Cranial Access Kits, Catalogue Nos
FDA Device · Class II · 2016-09-14 · Integra Lifesciences D B A Integra Pain Management - INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile
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All Integra Lifesciences D B A Integra Pain Management recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.