Z-2181-2012Class II

Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System...

Name: Z-2181-2012 Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System...
Creator: Kimberly-Clark Corporation
Published: 2012-04-27
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2012-04-27 / Terminated / root cause: design

FDA source

Kimberly-Clark Corporation began a recall of Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a... on 2012-04-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2181-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-27
Posted: 2012-08-09
Terminated: 2012-09-05
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.
Product code: DWJ System, Thermal Regulating
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2181-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2181-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code DWJ

K033021Class IIKimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsKimberly-Clark Corp. / cleared 2003-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)