Recall Z-2355-2019— Cincinnati Sub-Zero Products LLC, a Gentherm Company

Name: FDA recall Z-2355-2019
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. It names one FDA 510(k) clearance: K120081. Product: Norm-O-Temp model 111Z. 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

510(k) clearances named in this recall

1 on FDA's record

K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADSCincinnati Sub-Zero Products, Inc.·cleared 2012-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Norm-O-Temp model 111Z

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.