Z-1817-2011

115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01...

Name: Z-1817-2011 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2010-10-18
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2010-10-18 / Terminated / root cause: labeling and UDI

FDA source

Cincinnati Sub-Zero Products Inc began a recall of 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to... on 2010-10-18. The reason FDA records is "The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1817-2011
Status: Terminated
Initiated: 2010-10-18
Posted: 2011-03-30
Terminated: 2013-03-08
Recalling firm: Gentherm Medical, LLC
Product: 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
Product code: DWJ System, Thermal Regulating
Reason for recall: The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 10/18/2010 & 11/5/2010 the firm sent URGENT Medial Device Field Action letters, dated 10/18/2010, to their customers. The letters identified the affected product and stated the reason for recall. Customers were instructed to immediately collect and discard all affected product Operation and Operation/Technical Service manuals currently in their possession. They were to replace all the discarded manuals with the revised versions that were provided with the letter. The enclosed response form should be completed and returned by fax to 513-772-9119, scanned and e-mailed to [email protected]. If the product had been further distributed, then those customers should also be identified and notified of the field action via a copy of the letter. Customers should direct questions to the field action coordinator, David Niehaus at 513-773-8810 ext. 3234.
Quantity in commerce: 763 - 115V Blanketrol III Model 233; & 133 - 115V CoolBlue Model 25-01
Distribution: Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.
Product codes and lots: Model 233, Serial Numbers 061-3-00001 through 101-3-01389 and Model 25-01, Serial Numbers 073-CB-00001 through 094-CB-00138.

Product code DWJ

K101589Class IIBlanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsCincinnati Sub-Zero Products, Inc. / cleared 2010-09-20

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)