Recall Z-2291-2019— Cincinnati Sub-Zero Products LLC, a Gentherm Company

Name: FDA recall Z-2291-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Class III · Terminated

Class III FDA medical device recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, initiated 2019-07-19, terminated 2020-05-13. FDA's recall record names no specific 510(k) clearance for this event. Product: MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.. Reason: Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage.

Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Classification: Class III
Status: Terminated
Initiated: 2019-07-19
Terminated: 2020-05-13
Firm location: Cincinnati, OH, United States

Product description

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Reason for recall

Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage

Data sourced from openFDA. This site is unofficial and independent of the FDA.