Micro-temp LT System recall
MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Why was Micro-temp LT System recalled?
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers 141-LT-02789 through 193-LT-05137 UDI: 10613031881165
- Product
- MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
- Recalling firm
- Cincinnati Sub-Zero Products LLC, a Gentherm Company
- Quantity
- 2079 units
- Distribution
- Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
- Recall date
- August 28, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)