Recall Z-1825-2017— Cincinnati Sub-Zero Products Inc

Name: FDA recall Z-1825-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-09

Class II · Terminated

Class II FDA medical device recall by Cincinnati Sub-Zero Products Inc, initiated 2017-03-09, terminated 2017-12-18. It names one FDA 510(k) clearance: K122813. Product: Hemotherm CE, model 400CE, Heater-Cooling Device. Reason: Improperly rated fuses were used in the manufacture of the device..

Recalling firm: Cincinnati Sub-Zero Products Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Terminated: 2017-12-18
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K122813 — HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEMCincinnati Sub-Zero Products, Inc.·cleared 2012-12-18

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

Hemotherm CE, model 400CE, Heater-Cooling Device

Reason for recall

Improperly rated fuses were used in the manufacture of the device.

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