Home / Recalls / Medical Devices
Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the
Recalled September 25, 2013 · FDA recall Z-2260-2013 · Integra LifeSciences Corp.
Hazard
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping. · FDA Class II
Units
8,648
Sold at
Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
Description
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Product
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are 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 CSF, and to monitor ICP.
Manufacturer(s)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →