Z-0372-2012

Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622...

Name: Z-0372-2012 Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2011-09-26
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2011-09-26 / Terminated / root cause: manufacturing process

FDA source

Cincinnati Sub-Zero Products Inc began a recall of Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe... on 2011-09-26. The reason FDA records is "Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0372-2012
Status: Terminated
Initiated: 2011-09-26
Posted: 2012-01-11
Terminated: 2013-08-13
Recalling firm: Gentherm Medical, LLC
Product: Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/monitoring device to continuously measure/monitor a patient's core body temperature.
Product code: BZT Stethoscope, Esophageal, With Electrical Conductors
Reason for recall: Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cincinnati Sub-Zero Products, Inc., issued an "Urgent Medical Device Field Action" letter on November 1, 2011 to all affected customers. The letter includes; description of product and problem, and a list of the affected lot numbers. The letter instructs the customers to discontinue use of the device. All unused product is to be returned to the Biomedical/Clinical Engineering and/or Service Department for an replacement and all used probes are to be disposed of in accordance with hospital policy. The customers are also instructed to complete and return an attached Recall Response Form ASAP. For additional information, customers may contact the Beatrice Washington at 1-800-989-7373 or (513) 772-8810.
Quantity in commerce: 369,680
Distribution: Nationwide distribution and Canada.
Product codes and lots: The following lot codes are subject to recall: 12998, 12999, 19257, 19257A, 19644, 21536, 21537, 27446, 29112, 31081, 31082, 32209, 37281, 38522, 8996, D414723, D416607, D420120, D421702, D423801, D423908, D525212, D515408, D516607, D517108, D520709, D524107, D525502, D527632, D530518, D624011, D624012, D634834 D706611, D709119, D720450, D721118, D722015, and D727416.

Product code BZT

K072621Class IIEsophageal/rectal Temperature Probe and Esophageal Stethoscope with Temperature SensorCincinnati Sub-Zero Products, Inc. / cleared 2007-12-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)