Recall Z-0101-2015 ยท BSB Warmer, Blood, Non-Electromagnetic Radiation
Estill Medical Technologies, Inc
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.
| Date | Oct 21, 2014 (initiated Jul 25, 2014) |
| Status | Terminated |
| 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 |
| Root cause | 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. F |
| Quantity | 6,886 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Serbia. |
| FDA record | Open on fda.gov |