Recall Z-0101-2015— Estill Medical Technologies, Inc

Name: FDA recall Z-0101-2015
Creator: U.S. Food and Drug Administration
Published: 2014-07-25

Class II · Terminated

Class II FDA medical device recall by Estill Medical Technologies, Inc, initiated 2014-07-25, terminated 2015-08-21. It names 2 FDA 510(k) clearances: K012031, K984640. 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.. 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.

Recalling firm: Estill Medical Technologies, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-07-25
Terminated: 2015-08-21
Firm location: Dallas, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K012031 — MODIFICATION TO THERMAL ANGELEstill Medical Technologies, Inc.·cleared 2001-07-26
K984640 — THERMAL ANGELEstill Medical Technologies, Inc.·cleared 1999-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.