BEUDAMED
    FDA Recall Terminated

    FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).

    Recall: Z-0781-2010 · Initiated November 14, 2009

    Recall

    Recall Number
    Z-0781-2010
    Event Number
    53947
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 14, 2009
    Posted
    February 4, 2010
    Terminated
    January 25, 2012
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528

    Description

    FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).

    Reason

    Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.

    Action

    On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.

    Distribution

    Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands.

    Quantity

    1,095 Blankets