BEUDAMED
    FDA Recall Terminated

    Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065

    Recall: Z-0137-2008 · Initiated May 14, 2007

    Recall

    Recall Number
    Z-0137-2008
    Event Number
    44928
    Firm
    Freedom Designs Inc
    FEI Number
    2081283
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2007
    Posted
    December 19, 2007
    Terminated
    July 14, 2008
    Address
    2241 N Madera Rd, Simi Valley, CA, 93065-1762

    Description

    Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065

    Reason

    Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.

    Action

    Urgent Field Correction Notification letters were sent to customers on May 15, 2007 via US Postal return receipt requested. Consignees were notified via delivery of a field correction package consisting of: (1) A letter to the dealer (2) FAQ sheet clarifying their responsibility (3) A corrective/preventive action tracking sheet specific for the consignees affected units (4) Replacements of anti-tipper assembly for each unit shipped with an instruction sheet. A Notice was also posted on the Freedom Designs website. Correction will be made to the consumer level

    Distribution

    Nationwide: including states of AL, CA, FL, CO, GA, KS, LA, MI, MS, NC, OH, TN, TX, and VA

    Quantity

    41 units