BEUDAMED
    FDA Recall Terminated

    Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children.

    Recall: Z-0318-2009 · Initiated September 12, 2008

    Recall

    Recall Number
    Z-0318-2009
    Event Number
    49572
    Firm
    Community Products, LLC
    FEI Number
    1319061
    Product Code
    INN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 12, 2008
    Posted
    December 5, 2008
    Terminated
    March 15, 2010
    Address
    2032 Route 213, Rifton, NY, 12471

    Description

    Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. The product is used as a hip strap chair for children.

    Reason

    Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. If a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.

    Action

    On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps. For questions or additional information, contact Rifton Equipment at 1-800-571-8198.

    Distribution

    Worldwide Distribution including USA and countries of Spain and Great Britain.

    Quantity

    Potentially 147 units may be affected.