Events

Recall of Device Recall Thermal Angel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Estill Medical Technologies, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-2015
  • Event Initiated Date
    2014-07-25
  • Event Date Posted
    2014-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130149
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Warmer, blood, non-electromagnetic radiation - Product Code BSB
  • 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.

Device

Device Recall Thermal Angel
  • Model / Serial
    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
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Serbia.
  • Product 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.
  • Manufacturer
    Estill Medical Technologies, Inc

Manufacturer

Estill Medical Technologies, Inc
  • Manufacturer Address
    Estill Medical Technologies, Inc, 4144 N Central Expy Ste 260, Dallas TX 75204-3100
  • Manufacturer Parent Company (2017)
    Estill Medical Technologies Inc.
  • Source
    USFDA