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
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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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