Device product
Norm-O-Temp model 111W
Z-2356-2019
Product summary
- Event
- Event 83376
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1063
- Official record key
device-enforcement:Z-2356-2019
Official wording
Reason: The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Code information: Serial number Range: 091-N6669-192-N7901 UDI: 10613031861563, 10613031861570, 10613031861587, 10613031861617 Part # 86156, 86157,86158, 86161
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
Derived failure modes
-
Unknown
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.