Reported Aug 15, 2012 · Terminated

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

Kimberly-Clark Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Kimberly-Clark Corporation · 1400 Holcomb Bridge Rd · Roswell, GA · 30076

Is this the product you have?

  • 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.
Lot codes and dates
  • 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

    123 of 123 codes

    • 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
Amount recalled
129 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 5, 2012 · Data as of Sep 19, 5:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.