BEUDAMED
    FDA Enforcement Class II Terminated

    Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

    Recall: Z-0451-2013 · Reported December 5, 2012

    Enforcement

    Recall Number
    Z-0451-2013
    Event ID
    63649
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kimberly-Clark Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 5, 2012
    Initiation Date
    September 16, 2010
    Classification Date
    November 29, 2012
    Termination Date
    December 20, 2012
    Address
    1400 Holcomb Bridge Rd, N/A, Roswell, GA, 30076, United States

    Description

    Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.

    Reason

    Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

    Code Info

    Serial Number - SA09043017, SA09043019, SA0904320, SA09043018, SA09043015, SA09043012, SA09043016, SA09043014, SA09043013, SA09043009, SA09043011, SA09043010, SA09043008, SA09043007, SA09043006, SA09043003, SA09043005, SA09043004, SA09043002, SA09043001, SA09020013, SA09020012, SA09020014, SA09020011, SA09020010, SA09020009, SA0902008, SA09020006, SA09020007, SA08343100, SA09020004, SA09020005, SA09020002, SA09020003, SA09020001, SA08343099, SA08343098, SA08343097, SA08343096, SA08343095, SA08343094, SA08343093, SA08343092, SA08343091, SA08343090, SA08343089, SA08343087, SA08343088, SA08343086, SA08343085, SA08343083, SA08343084, SA08343053, SA08343073, SA08288014, SA08288002, SA08343054, SA08343082, SA08343081, SA08343080, SA08343079, SA08343078, SA08343077, SA08165007, SA08343076, SA08343075, SA08343074, SA08343072, SA08343055, SA08288007, SA08343071, SA08343070, SA08343069, SA08343068, SA08343067, SA08343066, SA08343065, SA08343064, SA08343063, SA08343059, SA08343058, SA08343062, SA08343061, SA08343060, SA08343056, SA08343057, SA08288012, SA08288017, SA08288016, SA08288015, SA08288013, SA08288011, SA08288009, SA08288006, SA08288003, SA08288010, SA08288008, SA08288004, SA08288005, SA08288001, SA08165013, SA08165014, SA08165015, SA08165018, SA08165016, SA08165017, SA08165006, SA08165005, SA08165011, SA08165012, SA08165010, SA08165009, SA08165004, SA08165008, SA08165002, SA08165003, SA08144035, SA08144030, SA08165001, SA08144034, SA08144033, SA08144032, SA08144031, SA08144029, SA08144028, SA08144025, SA08144027, SA08144021, SA08144026, SA08144024, SA08144023, SA08144022, SA08136010, SA08136006, SA08136003, SA08136009, SA08136005, SA08136004, SA08136007, SA08136001, SA08136002, SA08136008, SA08094129, SA08094137, SA08094141, SA08094136, SA08094150, SA08094153, SA08094152, SA08094151, SA08094149, SA08094145, SA08094148, SA08094147, SA08094143, SA08094146, SA08094142, SA08094144, SA08094140, SA08094139, SA08094138, SA08094134, SA08094130, SA08094132, SA08094135, SA08094131, SA08094133, SA08094127, SA08094128, SA08094125, SA08094126, SA08094124, SA08017044, SA08017049, SA08017045, SA08017040, SA08017034, SA08017035, SA08017041, SA08017047, SA08017042, SA08017043, SA08017048, SA08017039, SA08017046, SA08017038, SA08017037, SA08017030, SA08017036, SA08017028, SA08017029, SA08017027, SA08017033, SA08017031, SA08017032, SA07344022, SA07344029, SA07344028, SA07344026, SA07344027, SA07344030, SA07344021, SA07344023, SA07344024, SA07344025, SA07320002, SA07320001, SA07320014, SA07320015, SA07320013, SA07320011, SA07320012, SA07320006, SA07320005, SA07320008, SA07320010, SA07320009, SA07320007, SA07320004, SA07320003, SA07261006, SA07257008, SA07261004, SA07261007, SA07261002, SA07257004, SA07257007, SA07257003, SA07257002, SA07261005, SA07261008, SA07261003, SA07261001, SA07257005, SA07257006, SA07257001, SA07250005, SA07250004, SA07250002, SA07250003, SA07250001, SA07228007, SA07228008, SA07228001, SA07228002, SA07228003, SA07228004, SA07228005, SA07228006, SA07180006, SA07180005, SA07180004, SA07180003, SA07180002, SA07180001, SC07171006, SC07171005, SC07171004, SC07171003, SC07171002, SC07171001

    Distribution

    Nationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI

    Quantity

    400 units