BEUDAMED
    FDA Recall Terminated

    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

    Recall: Z-2672-2014 · Initiated March 31, 2014

    Recall

    Recall Number
    Z-2672-2014
    Event Number
    67912
    Firm
    Vidacare Corporation
    FEI Number
    3007134520
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 31, 2014
    Posted
    September 22, 2014
    Terminated
    January 30, 2015
    Address
    4350 Lockhill Selma Rd, Suite 150, San Antonio, TX, 78249-2162

    Description

    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

    Reason

    The voluntary recall is due to the needle set not meeting its specifications.

    Action

    Vidacare sent an Urgent Medical Device Recall Notification to all of its customers on March 31, 2014.The letter identified the product the problem and the action to be taken by the customers. The firm asked its customers to return the affected lot for a replacement. Customers were instructed: 1. If you have affected stock, immediately discontinue use and quarantine any product with the part number and lot number as identified above 2 To return product. complete the enclosed Medical Device Recall Acknowledgment and Return Response Form and fax it to 1 866-431-6194, Attn "Customer Service" This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Vidacare Corporation and to facilitate replacement product if one has not already been provided 3. If you have already used the affected stock. please complete the enclosed Medical Device Recall Acknowledgement and Return Response Form and fax it to 1-866-431- 6194, Attn" Customer Service". This will allow us to document your receipt of the letter. Vidacare Corporation is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-479-8500.

    Distribution

    Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada

    Quantity

    172