FDA Device recall Z-1825-2017
Hemotherm CE, model 400CE, Heater-Cooling Device
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Hemotherm CE, model 400CE, Heater-Cooling Device by Cincinnati Sub Zero Products, citing improperly rated fuses were used in the manufacture of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1825-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-09 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cincinnati Sub Zero Products |
| Distribution | AL, AZ, CA, CO, DE, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WI |
Product
Hemotherm CE, model 400CE, Heater-Cooling Device
Reason
Improperly rated fuses were used in the manufacture of the device.
Identifiers
| code_info | 151-10283CE, 151-10284CE, 151-10285CE, 151-10286CE, 151-10287CE, 151-10290CE, 151-10291CE, 151-10292CE, 151-10293CE, 15…151-10283CE, 151-10284CE, 151-10285CE, 151-10286CE, 151-10287CE, 151-10290CE, 151-10291CE, 151-10292CE, 151-10293CE, 151-10294CE, 151-10295CE, 151-10296CE, 151-10297CE, 151-10298CE, 151-10299CE, 152-10300CE, 152-10301CE, 152-10302CE, 152-10303CE, 152-10304CE, 152-10310CE, 152-10311CE, 152-10312CE, 152-10313CE, 152-10314CE, 153-10321CE, 153-10322CE, 153-10323CE, 153-10324CE, 154-10335CE, 154-10336CE, 154-10337CE, 154-10338CE, 154-10339CE, 154-10340CE, 154-10341CE, 154-10342CE, 154-10343CE, 154-10344CE, 154-10345CE, 154-10346CE, 154-10347CE, 154-10348CE, 154-10349CE, 154-10350CE, 154-10351CE, 154-10352CE, 154-10353CE, 154-10354CE, 154-10355CE, 154-10356CE, 154-10357CE, 154-10358CE, 154-10359CE, 154-10360CE, 154-10361CE, 154-10362CE, 154-10363CE, 154-10364CE, 154-10365CE, 154-10366CE, 154-10367CE, 154-10368CE, 154-10369CE, 154-10370CE, 154-10371CE, 154-10373CE, 154-10374CE, 154-10375CE, 161-10376CE, 161-10377CE, 161-10378CE, 161-10379CE, 161-10380CE, 161-10381CE, 161-10382CE, 161-10383CE, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1825-2017%22
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