Recall Z-2356-2019— Cincinnati Sub-Zero Products LLC, a Gentherm Company

Name: FDA recall Z-2356-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-20

Class II · Terminated

Class II FDA medical device recall by Cincinnati Sub-Zero Products LLC, a Gentherm Company, initiated 2019-06-20, terminated 2020-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Norm-O-Temp model 111W. Reason: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage..

Recalling firm: Cincinnati Sub-Zero Products LLC, a Gentherm Company
Classification: Class II
Status: Terminated
Initiated: 2019-06-20
Terminated: 2020-06-09
Firm location: Cincinnati, OH, United States

Product description

Norm-O-Temp model 111W

Reason for recall

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

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