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U.S. Department of Health and Human Services

Class 3 Device Recall MICROTEMP LT Model 749

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  Class 3 Device Recall MICROTEMP LT Model 749 see related information
Date Initiated by Firm July 19, 2019
Create Date August 19, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-2291-2019
Recall Event ID 83387
Product Classification Pack, hot or cold, water circulating - Product Code ILO
Product MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.
Code Information Serial Numbers 141-LT-02789 through 193-LT-05137  UDI: 10613031881165
Recalling Firm/
Manufacturer		 Cincinnati Sub-Zero Products LLC, a Gentherm Company
12011 Mosteller Rd
Cincinnati OH 45241-1528
For Additional Information Contact SAME
513-772-8810
Manufacturer Reason
for Recall		 Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
FDA Determined
Cause 2		 Under Investigation by firm
Action Gentherm issued an Urgent Medical Device Notification on 7/19/19 via UPS informing users of the problem, health risk and action to take :Immediately examine your inventory and update manual(s) subject to recall and ensure that obsolete manuals are removed from service In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. INSTRUCTIONS TO CUSTOMERS: 1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals maybe accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at 1-888-437-0608.
Quantity in Commerce 2079 units
Distribution Nationwide Foreign: AUSTRALIA CANADA CHILE COLOMBIA COLOMBIA GUATEMALA ISRAEL JAPAN NETHERLANDS POLAND SINGAPORE SOUTH KOREA UNITED ARAB EMIRATES
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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