BEUDAMED
    FDA Recall Terminated

    Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.

    Recall: Z-1613-2012 · Initiated April 12, 2012

    Recall

    Recall Number
    Z-1613-2012
    Event Number
    61657
    Firm
    Galil Medical, Inc.
    FEI Number
    3004462490
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 12, 2012
    Posted
    May 16, 2012
    Terminated
    August 16, 2012
    Address
    4364 Round Lake Rd, W Arden Hills, MN, 55112

    Description

    Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.

    Reason

    Galil Medical is recalling 17G Cryoablation Needle Holder, FPRPR 4014. This voluntary recall has been initiated due to the possibility of excessive bioburden on the Needle Holders.

    Action

    Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.

    Quantity

    26 kits