FDAFDA · Food and drugs·Recall number Z-2181-2012
Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Published August 15, 2012 · Recall initiated: April 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Kimberly-Clark Corporation
- Distributor
- Nationwide Distribution-including the states of AZ, CA, CO, DE, FL, GA, IA, ID, IN, IL, KS, KY, LA, MA, MD, ME, MO, MS, NE, NM, OH, OR, PA, RI, SC, TN, TX, VA, WI and WV.
- Lot
- Catalogue #01000-01 and 01000-01R, Units with 4-Digit Serial Numbers: Lot #4297, 4324, 4332, 4519, 4559, 4572; Units with 10 Character Serial Numbers: SA08017027, SA08017028, SA08017029, SA08017030, SA08017031, SA08017032, SA08017033, SA08017034, SA08017035, SA08017036, SA08017037, SA08017038, SA08017039, SA08017040, SA08017041, SA08017042, SA08017043, SA08017044, SA08017045, SA08017046, SA08017047, SA08017048, SA08017049, SA08343100, SA11137004, SA11137005, SA11137006, SA11137007, SA11137008, SA08094124, SA08094125, SA08094126, SA08094127, SA08094128, SA08094129, SA08094130, SA08094131, SA08094132, SA08094133, SA08094134, SA08094135, SA08094136, SA08094137, SA08094138, SA08094139, SA08094140, SA08094141, SA08094142, SA08094143, SA08094144, SA08094145, SA08094146, SA08094147, SA08094148, SA08094149, SA08094150, SA08094151, SA08094152, SA08094153, SA09020004, SA09020005, SA09020007, SA09020008, SA09020010, SA09020013, SA11298011, SA11298012, SA11298013, SA11298014, SA11298015, SA11298016, SA11298017, SA11298018, SA11298019, SA08136001, SA08136002, SA08136003, SA08136004, SA08136005, SA08136006, SA08136007, SA08136008, SA08136009, SA08136010, SA09043001, SA09043002, SA09043003, SA09043004, SA09043007, SA09043008, SA09043009, SA09043010, SA09043010, SA09043011, SA09043012, SA09043013, SA09043014, SA09043015, SA09043016, SA09043017, SA09043018, SA09043019, SA09043020, SA08343061, SA08343082, SA08343083, SA08343084, SA08343085, SA08343086, SA08343087, SA08343088, SA08343089, SA08343090, SA08343091, SA08343092, SA08343093, SA08343094, SA08343095, SA08343096, SA10337006, SA10337007, SA10337008, SA10337009 and SA10337010.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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