BEUDAMED
    FDA Enforcement Class II Terminated

    Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.

    Recall: Z-1604-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1604-2016
    Event ID
    73641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ferno-Washington Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 11, 2016
    Initiation Date
    March 10, 2016
    Classification Date
    May 4, 2016
    Termination Date
    August 23, 2016
    Address
    70 Weil Way, Wilmington, OH, 45177-9371, United States

    Description

    Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.

    Reason

    On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled Pediatric conta

    Code Info

    Strap Kit Adult Model 444

    Distribution

    Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..

    Quantity

    270