BEUDAMED
    FDA Recall Terminated

    Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)

    Recall: Z-0204-2015 · Initiated October 1, 2014

    Recall

    Recall Number
    Z-0204-2015
    Event Number
    69367
    Firm
    Roscoe Medical Inc
    FEI Number
    3005182235
    Product Code
    ITJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 1, 2014
    Posted
    November 12, 2014
    Terminated
    February 22, 2017
    Address
    21973 Commerce Pkwy, Strongsville, OH, 44149-5558

    Description

    Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)

    Reason

    The caster may separate completely from the device frame causing injury to user.

    Action

    The firm, Roscoe Medical, issued a "URGENT RECALL NOTICE-Timely Response Required" Quarantine Communication to customers between 09/08/2014 and 09/10/2014. The notice identified affected products as 30194, serial number range MH140407092MH140407291, the problem and actions to be taken. The customers were instructed NOT to use this product and to destroy any affected product that may be in their inventory/control; immediately complete and return the attached Recall Response Form/Certificate of Destruction to Roscoe Medical- "Transport Rollator Recall" within 15 days of receipt of the recall notification via fax to (440) 572-4261 or email: [email protected], even if you do not have any affected product; and notify your customers immediately of this product recall. Should you have any questions, contact Roscoe Medical Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST - 5:00 pm EST.

    Distribution

    Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.

    Quantity

    831 units