Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) ...
FDA Device Recall #Z-0551-2014 — Class II — November 26, 2013
Recall Summary
| Recall Number | Z-0551-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 731 |
Product Description
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.
Distribution Pattern
Nationwide Distribution
Lot / Code Information
Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014
Other Recalls from Integra LifeSciences Corp. d.b.a. Int...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2868-2016 | Class II | PHS Spinal Tray 24G Gertie Marx, Catalogue No. ... | Aug 24, 2016 |
| Z-2733-2016 | Class II | Integra Cranial Access Kits, Catalogue Nos. INS... | Aug 24, 2016 |
| Z-2684-2016 | Class II | INTEGRA Spinal Tray, Catalogue No: 3404875, Con... | Aug 4, 2016 |
| Z-0193-2016 | Class II | Integra¿ Bone Marrow Biopsy Trays Catalogue No.... | Sep 22, 2015 |
| Z-2056-2015 | Class II | Integra¿ Long Epidural Steroid Injection Needle... | May 1, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.