BEUDAMED
    FDA Recall Terminated

    Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.

    Recall: Z-0832-2012 · Initiated October 14, 2011

    Recall

    Recall Number
    Z-0832-2012
    Event Number
    60615
    Firm
    Nemschoff Chairs, Inc.
    FEI Number
    3001591966
    Product Code
    NZG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 14, 2011
    Posted
    February 1, 2012
    Terminated
    November 27, 2012
    Address
    909 N 8th St, Sheboygan, WI, 53081-4056

    Description

    Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.

    Reason

    To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.

    Action

    The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.

    Quantity

    1214 units.