Home / Recalls / Cincinnati Sub-Zero Products LLC, a Gentherm Company / Z-2355-2019

Z-2355-2019 Class II Terminated

Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm Company — Cincinnati, OH

FDA device recall Z-2355-2019 was initiated by Cincinnati Sub-Zero Products LLC, a Gentherm Company on June 20, 2019 and is designated Class II. Reason for recall: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. The recall status is terminated (terminated June 9, 2020). Affected quantity: 674.

Recall Details

Product Type: Devices
Report Date: September 11, 2019
Initiation Date: June 20, 2019
Termination Date: June 9, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 674

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.

Distribution Pattern

Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore

Code Information

Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Other recalls by Cincinnati Sub-Zero Products LLC, a Gentherm Company

Z-2291-2019 Class III — MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to wa (July 19, 2019)
Z-0419-2020 Class II — CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - P (July 2, 2019)
Z-0418-2020 Class II — Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: T (July 2, 2019)
Z-0417-2020 Class II — Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature man (July 2, 2019)
Z-2356-2019 Class II — Norm-O-Temp model 111W (June 20, 2019)
Z-0825-2019 Class II — Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: Th (December 19, 2018)
Z-0063-2019 Class II — Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservo (September 4, 2018)