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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 63649
Product Type Devices
Status Completed
Recalling Firm Kimberly-Clark Corporation
City Roswell
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-09-16
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern 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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. 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 Class II Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately. 400 units Z-0451-2013
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