Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. 의 리콜

Recall

29687

Class 2

Z-1332-04

2004-07-27

2004-08-10

Terminated

United States

2012-03-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34355

Battery pack may overheat and cause patient burns.

Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005