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Recall Observatory FDA recall evidence

Device 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.

Z-0101-2015

July 25, 2014

Class II

Product summary

Firm
Estill Medical Technologies, Inc
Event
Event 69242
Status
Terminated
Classification
Class II
Quantity
6,886
Official record key
device-enforcement:Z-0101-2015

Official wording

Reason: 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

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

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Serbia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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