Recall Z-2260-2013 ยท HGB Clip, Tubal Occlusion
Integra LifeSciences Corp. d.b.a. Integra Pain Management
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.
| Date | Sep 19, 2013 (initiated Sep 4, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | Integra sent an Urgent Voluntary Medical Device Recall letter dated September 4, 2013, to all affected customers that have been shipped unexpired affected product lots of Integra Cranial Access Kits, Catalogue No.'s INSHITH, INSHITHND, INSHITHRZN.The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review their inventory and immediately stop the use or distribution of any affected product. Customers were instructed to identify and report to Integra if they do or do not have any of the affected product lots. Customers were adv |
| Quantity | 8,648 |
| Distribution | Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC, Jun 5, 1996 |