BEUDAMED
    FDA Recall Terminated

    PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.

    Recall: Z-0201-06 · Initiated March 28, 2003

    Recall

    Recall Number
    Z-0201-06
    Event Number
    34010
    Firm
    Ferno-Washington Inc
    FEI Number
    1523574
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2003
    Posted
    November 26, 2005
    Terminated
    October 29, 2008
    Address
    70 Weil Way, Wilmington, OH, 45177-9371

    Description

    PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.

    Reason

    The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.

    Action

    The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.

    Distribution

    The product was distributed nationwide to 27 states: TN, MA, VT, IL, KY, NY, SC, WI, TX, MO, NH, CO, GA, NC, CA, VA, IA, PA, CT, OH, NJ, ID, WV, AL, AR, ME and IN.

    Quantity

    2188 total stretchers