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FDA (Device enforcement)Recalled 2019-06-20closedclass ii

Cincinnati Sub-Zero Products LLC, a Gentherm Company: Norm-O-Temp model 111Z

Is my product affected?

Norm-O-Temp model 111Z

  • UPC 10613031861549
  • UPC 10613031861532

Check against the official notice below — it lists the full affected range.

What happened

Cincinnati Sub-Zero Products LLC is recalling 674 units of its Norm-O-Temp model 111Z due to a missing warning in the product manual. The manual fails to instruct users that temperatures exceeding 40 Celsius for extended periods can cause tissue damage. The affected units have serial numbers between 113-0001N and 192-0798N and were distributed to customers in multiple U.S. states and internationally to countries including Canada, Mexico, the United Kingdom, Japan, Germany, South Korea, and others.

The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Details from the source

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: 674 Lot/code info: Serial Number Range : 113-0001N-192-0798N UDI : 10613031861549 and 10613031861532 Part # 86153, 86154

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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