| Date Initiated by Firm | August 24, 2007 |
|---|
| Date Posted | December 22, 2007 |
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| 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 |
| FEI Number |
3006525760
|
Recalling Firm/
Manufacturer |
BatteryZone, Inc.
14 Culnen Dr
Branchburg NJ 08876-5400
|
| For Additional Information Contact | Ms. Amanda Wilson
732-652-5270 |
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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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