BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2260-2013 · Initiated September 4, 2013

    Recall

    Recall Number
    Z-2260-2013
    Event Number
    66186
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    FEI Number
    1000138491
    Product Code
    HGB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    September 4, 2013
    Posted
    September 19, 2013
    Terminated
    January 28, 2014
    Address
    3498 West 2400 South, # 1050, Salt Lake City, UT, 84119

    Description

    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.

    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.

    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 advised how to return any affected product lot numbers in their possession. Effectiveness Checks will be conducted to determine the level of customers who: - Integra has verified, have been notified, and / or acknowledged the recall either by returning the acknowledgement form. - Indicate they will be returning / have returned unexpired affected product lots of kits. Any affected product lot numbers that are returned from consignees will be forwarded to the Integra Salt Lake City, UT facility for final disposition per its site QMS processes. Customers with questions were advised to contact Customers Service at 1-855-532-1723. For questions regarding this recall call 801-886-9505.

    Distribution

    Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.

    Quantity

    8,648