BEUDAMED
    FDA Enforcement Class II Terminated

    Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.

    Recall: Z-1071-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1071-2013
    Event ID
    63622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    J T Posey Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    October 31, 2012
    Classification Date
    April 9, 2013
    Termination Date
    July 17, 2014
    Address
    5635 Peck Rd, Arcadia, CA, 91006-5851, United States

    Description

    Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.

    Reason

    The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.

    Code Info

    The model/catalog number for the device is 2900. All lots are being recalled.

    Distribution

    Nationwide Distribution

    Quantity

    1673 units