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U.S. Department of Health and Human Services

Class 2 Device Recall lifecel

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  Class 2 Device Recall lifecel see related information
Date Initiated by Firm August 24, 2007
Date Posted December 22, 2007
Recall Status1 Terminated 3 on July 01, 2013
Recall Number Z-0523-2008
Recall Event ID 45814
Product Classification Battery - Product Code MKJ
Product life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.
Code Information All Replacement batteries: Part # : 7L877
Recalling Firm/
Manufacturer		 BatteryZone, Inc.
14 Culnen Dr
Branchburg NJ 08876-5400
For Additional Information Contact Ms. Amanda Wilson
732-652-5270
Manufacturer Reason
for Recall		 Marketed without 510 (K) approval
FDA Determined
Cause 2		 No Marketing Application
Action The original recall communication (important recall information) was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone. A second recall communication, Urgent Device Recall, was issued by Battery Zone dated 10/25, and was sent out to all customers (even those who had returned product) on 11/5/07. Both communications were sent by first class mail.
Quantity in Commerce 24 units
Distribution Nationwide; (primarily police/fire departments)
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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