Norm-O-Temp model 111W
Check against the official notice below — it lists the full affected range.
Cincinnati Sub-Zero Products LLC, a Gentherm Company, has recalled 1,063 units of the Norm-O-Temp model 111W product. The recall was issued because the product manual does not include instructions warning that temperatures exceeding 40 Celsius for extended periods can cause tissue damage. The affected products were distributed across multiple U.S. states and several countries including Canada, Mexico, United Kingdom, Germany, Japan, South Korea, China, and others. The recalled units have serial numbers ranging from 091-N6669 to 192-N7901 and specific UDI and part numbers are identified in the recall.
The record does not specify a remedy or what consumers should do if they own an affected product.
Written by software from the official notice below. Not reviewed by a lawyer.
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Reason for recall: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. Distribution: 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 Quantity: 1063 Lot/code info: Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.