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Recall

Class II — Kimberly-Clark Corporation

Recalling firmKIMBERLY-CLARK CORPORATION
Registered facilityKIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonError 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
ProductKimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
Quantity400 units
DistributionNationwide Distribution including AZ, AK, CA, CO, DE, DC, FL, GA. ID, IL, IN, IA, KS, KY, LA, MD, ME MA, MS, MO, MT, NE, NJ, NM, NV, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, and WI
Initiated2010-09-16
Classified2012-11-29
Terminated2012-12-20
Recall numberZ-0451-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Kimberly-Clark Corporation (Z-0451-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63649/

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