BEUDAMED
    FDA Recall Terminated

    IVEA Product Part Number 16100 Model 500A

    Recall: Z-3239-2017 · Initiated August 24, 2017

    Recall

    Recall Number
    Z-3239-2017
    Event Number
    78019
    Firm
    Firefly Medical, Inc.
    FEI Number
    3011390406
    Product Code
    FOX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 24, 2017
    Posted
    September 7, 2017
    Terminated
    November 1, 2019
    Address
    320 E Vine Dr, Ste 312, Fort Collins, CO, 80524-2332

    Description

    IVEA Product Part Number 16100 Model 500A

    Reason

    The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

    Action

    The recall notification is expected to begin on or before 9/8/17 after pin cap components are received for the corrections. Instructions in the recall notification letter do not include return of recall product. They are to be corrected in the field. If any units are returned, they will be labeled and quarantined until corrected by Firefly Medical personnel or the sub-contracted manufacturer supplier. The recall notification letter will be sent certified letter with return receipt.

    Distribution

    United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE

    Quantity

    570 units