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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 27, 2004
Date Posted August 10, 2004
Recall Status1 Terminated 3 on March 23, 2012
Recall Number Z-1332-04
Recall Event ID 29687
Product Classification Implant, Cochlear - Product Code MCM
Product Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
Code Information All Codes.
Recalling Firm/
Manufacturer		 Advanced Bionics Corporation
12740 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact Cedric Navarro
661-362-1963
Manufacturer Reason
for Recall		 Battery pack may overheat and cause patient burns.
FDA Determined
Cause 2		 Other
Action 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
Quantity in Commerce 2458
Distribution Nationwide and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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