BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0101-2015 · Initiated July 25, 2014

    Recall

    Recall Number
    Z-0101-2015
    Event Number
    69242
    Firm
    Estill Medical Technologies, Inc
    FEI Number
    3002587972
    Product Code
    BSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 25, 2014
    Posted
    October 21, 2014
    Terminated
    August 21, 2015
    Address
    4144 N Central Expy, Ste 260, Dallas, TX, 75204-3100

    Description

    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.

    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

    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.

    Distribution

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

    Quantity

    6,886