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Class 2 Device Recall lifecel |
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Date Initiated by Firm |
September 03, 2007 |
Date Posted |
January 26, 2008 |
Recall Status1 |
Terminated 3 on July 01, 2013 |
Recall Number |
Z-0521-2008 |
Recall Event ID |
45819 |
Product Classification |
Battery-Defibrillator - Product Code MKJ
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Product |
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc. |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Exocomm Tech Grp 1874 Catasauqua Rd Allentown PA 18109-3128
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For Additional Information Contact |
Ms. Amanda Wilson 732-652-5270
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Manufacturer Reason for Recall |
Marketed without a 510K
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FDA Determined Cause 2 |
PMA |
Action |
The original recall communication was sent out on 9/3/07 by Phoenix Solutions, a consultant to Battery Zone, as a Dear Valued Customer notice. A second recall communication, Urgent Device Recall Letter, was issued by Exxocom Technology Group dated 10/25, was sent out to all customer (even those who had returned product) on 11/5/07. Both communication were sent by first class mail, requesting return of batteries |
Quantity in Commerce |
46 units |
Distribution |
Worldwide-Batteries were distributed to dealers or distributors in CT, GA, MN, NC, NY, OH, OK, OR, PA and TN plus one Canadian Consignee |
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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