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U.S. Department of Health and Human Services

Class 2 Device Recall Thermal Angel

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  Class 2 Device Recall Thermal Angel see related information
Date Initiated by Firm July 25, 2014
Date Posted October 21, 2014
Recall Status1 Terminated 3 on August 21, 2015
Recall Number Z-0101-2015
Recall Event ID 69242
510(K)Number K012031  K984640  
Product Classification Warmer, blood, non-electromagnetic radiation - Product Code BSB
Product Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803

The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.
Code Information 06-2011; 07-2011; 08-2011; 09-2011; 03-2012; 04-2012; 05-2012; 06-2012; 07-2012; 08-2012; 01-2013; 03-2013; 08-2013; 09-2013; 10-2013; 11-2013; 12-2013; 01-2014; 02-2014; 04-2014; 07-2012; 02-2014
Recalling Firm/
Manufacturer		 Estill Medical Technologies, Inc
4144 N Central Expy Ste 260
Dallas TX 75204-3100
For Additional Information Contact
214-561-6001
Manufacturer Reason
for Recall		 Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in t
FDA Determined
Cause 2		 Device Design
Action Thermal Angel sent a Notice of Corrections letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to communicate the contents of the notice to all employees, consignees, consultants, or other parties affected by this correction. The firm also updated the labeling and instructions for use. For additional information cusotmers were instructed to contact Medical Technologies at (877)354-0286.The recalling firm issued a Notice of Corrections to its distributors and customers. For questions regarding this recall call 214-561-6001.
Quantity in Commerce 6,886
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Serbia.
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.
510(K) Database 510(K)s with Product Code = BSB and Original Applicant = ESTILL MEDICAL TECHNOLOGIES, INC.
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