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.
Enforcement
- Recall Number
- Z-0551-2014
- Event ID
- 66949
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 1, 2014
- Initiation Date
- November 26, 2013
- Classification Date
- December 20, 2013
- Termination Date
- April 9, 2014
- Address
- 3498 West 2400 South #1050, N/A, Salt Lake City, UT, 84119, United States
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.
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.
Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014
Nationwide Distribution
731