Reported Aug 28, 2019 · Terminated
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through…
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cincinnati Sub-Zero Products LLC, a Gentherm Company · 12011 Mosteller Rd · Cincinnati, OH · 45241-1528
Is this the product you have?
- MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
- Lot codes and dates
- Serial Numbers 141-LT-02789
- through 193-LT-05137 UDI10613031881165
- Amount recalled
- 2079 units
Where it was sold
- Nationwide
Why it was recalled
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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