Device recall: Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated…

Class II FDA enforcement event 63649. Recall start date: 16 Sep 2010. Status in the FDA record: Terminated. Termination date: 20 Dec 2012.

Reason for recall, in the words of FDA

Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

Class II, in the words of FDA

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

Kimberly-Clark Corporation started this device recall on 16 Sep 2010. The firm address in the FDA record is in Roswell, GA. FDA put the recall in Class II. FDA event 63649 has 1 product record. The first FDA enforcement report date is 5 Dec 2012. The record gives the status Terminated, with the termination date 20 Dec 2012.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide 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

Recalling firm

Kimberly-Clark Corporation, Roswell, GA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 63649: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0451-2013	Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.	400 units	Class II	Terminated	5 Dec 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2010: 37
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Kimberly-Clark Corporation
Initiated	Product (first record)	Type	Class	Records
1 Feb 2021	Scott Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales,	Drug	Class II	1
11 Dec 2018	U by Kotex Sleek, Regular Tampons, 18 Count	Device	Class II	4
29 Oct 2013	Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Ki	Device	Class II	1
24 Oct 2013	Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage:	Device	Class II	1
6 Mar 2013	KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose an	Device	Class II	1
5 Jul 2012	ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to pr	Device	Class II	2
14 Jun 2012	Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz	Drug	Class II	2
27 Apr 2012	Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Cont	Device	Class II	1
31 Dec 2010	ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical	Device	Class III	1
22 Jun 2010	Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic ga	Device	Class II	2

Kimberly-Clark Corporation: all 12 events

Official channels

FDA enforcement report Z-0451-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63649. https://recallregister.com/fda/ii/63649/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide 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
What quantity of product is in FDA event 63649?: The FDA record gives this quantity: 400 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2010 have the same class?: 89% of the 37 device events that started in 2010 are in Class II.