Agency classClass IIOur severity:High FDA (Devices)·Z-2181-2012·Announced 2012-08-15

Kimberly-Clark Patient Warming System Recalled for Fuse Holder Defect

Kimberly-Clark is recalling 129 Model 1000 Patient Warming System Control Units because a fuse holder defect may cause the device to fail or generate smoke.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to excessive heat and smoke generation, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Kimberly-Clark Corporation is recalling 129 units of the Kimberly Clark Patient Warming System - Model 1000 Control Unit. The device is a thermal regulating system indicated for monitoring and controlling patient temperature. The recall covers units with specific catalogue numbers and serial numbers distributed nationwide, including states such as 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.

The recall is due to a defect in the "fuse holder" that can lead to Control Unit failure. This failure may cause the device to lose its ability to warm and maintain the set temperature. Additionally, the defect may result in excessive heat within the fuse assembly, which could lead to the generation of smoke.

Healthcare facilities and users should identify affected units by checking the catalogue numbers (01000-01 and 01000-01R) and the specific 4-digit or 10-character serial numbers listed in the recall documentation. Users should stop using the affected units and contact Kimberly-Clark Corporation for instructions on repair or replacement.

The recalled product

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.
Manufacturer: Kimberly-Clark Corporation
Category: Medical Device — Patient Warming System
Hazard: fire
burn-injury
smoke
Affected units: 129

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Same manufacturer · Kimberly-Clark Corporation

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