Kimberly-Clark Corporation: 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.

Recall number

Z-2181-2012

Recalling firm

Kimberly-Clark Corporation

Product

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.

Status

Terminated

Initiated

2012-04-27

Posted

2012-08-09

Terminated

2012-09-05

Reason

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.

Root cause

Device Design

Action

Kimberly-Clark sent an "URGENT: FIELD CORRECTIVE ACTION NOTICE" dated April 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Corrective Action Response Form was attached for customers to complete and return. Contact the Field Corrective Action Coordinator at 770-587-7400 for questions regarding this notice.

Quantity

129 units

Distribution

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, serial or model codes

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.

510(k) numbers

["K033021"]

PMA numbers

not on file

Product code

DWJ

Firm FEI

1000015879

Firm city

Roswell

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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