BEUDAMED
    FDA Recall Terminated

    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

    Recall: Z-1817-2011 · Initiated October 18, 2010

    Recall

    Recall Number
    Z-1817-2011
    Event Number
    57004
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 18, 2010
    Posted
    March 30, 2011
    Terminated
    March 8, 2013
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241

    Description

    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

    Reason

    The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.

    Action

    On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to [email protected]. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.

    Distribution

    Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.

    Quantity

    763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01