BEUDAMED
    FDA Recall Terminated

    Acuject Variable Injection Needle

    Recall: Z-2089-2019 · Initiated June 14, 2019

    Recall

    Recall Number
    Z-2089-2019
    Event Number
    83135
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    FBK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 14, 2019
    Terminated
    April 2, 2021
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    Description

    Acuject Variable Injection Needle

    Reason

    Potential for occluded injection needles.

    Action

    Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.

    Distribution

    Distributed to China

    Quantity

    24