BEUDAMED
    FDA Recall Terminated

    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

    Recall: Z-0696-2016 · Initiated January 6, 2016

    Recall

    Recall Number
    Z-0696-2016
    Event Number
    73046
    Firm
    Global Healthcare Inc
    FEI Number
    1000140469
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 6, 2016
    Posted
    February 3, 2016
    Terminated
    March 25, 2016
    Address
    11350 Old Roswell Rd, Suite 700, Alpharetta, GA, 30009-2291

    Description

    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

    Reason

    Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

    Action

    Global Healthcare sent an "Urgent: DEVICE RECALL" letter dated January 6, 2015 to its Customer by email. The letter described the product, problem and actions to be taken. The customer was instructed to immediately examine its inventory to determine if you have any of the Model ET-20 on hand; if so, immediately discontinue distributing product; and complete and return the Distributor Device Recall Response Form by email. Additionally, if you have further distributed any of the product, immediately contact your accounts; advise them of recall situation and have them return their outstanding recalled stocks to you. Any returned product will be destroyed by the distributor upon receipt of all affected product. If you require further assistance, please call 770-522-7520.

    Distribution

    US Distribution to state of: GA only.

    Quantity

    2,000 cases (100 individual units per case)