Reported Jan 1, 2014 · Terminated
Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole…
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. d.b.a. Integra Pain Management · 3498 West 2400 South #1050 · Salt Lake City, UT · 84119
Is this the product you have?
- 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.
- Lot codes and dates
- Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014
- Amount recalled
- 731
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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