Is Norm-O-Temp model 111Z recalled?

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. Status: Voluntary: Firm initiated Initial Firm Notification: Letter 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 Australia Indonesia Venezuela Singapore

Medium RiskFDA Device

Cincinnati Sub-Zero Products LLC, a Gentherm Company: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Agency Publication Date: September 4, 2019

Affected Products

Product: Norm-O-Temp model 111Z

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

Product: Norm-O-Temp model 111W

Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83376

Status: Resolved

Manufacturer: Cincinnati Sub-Zero Products LLC, a Gentherm Company

Manufactured In: United States

Units Affected: 2 products (674; 1063)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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