BEUDAMED
    FDA Recall Terminated

    InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.

    Recall: Z-2122-2014 · Initiated June 4, 2014

    Recall

    Recall Number
    Z-2122-2014
    Event Number
    68470
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 4, 2014
    Posted
    July 28, 2014
    Terminated
    March 14, 2016
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    Description

    InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.

    Reason

    Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec

    Action

    On 06/30/1014 the firm sent "Urgent Medical Device Notification" letters to their customers.

    Distribution

    Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.

    Quantity

    11,632 units