Class 2 Device Recall lifecel

• Date Initiated by Firm: September 03, 2007
• Date Posted: January 26, 2008
• Recall Status: Terminated on July 01, 2013
• Recall Number: Z-0521-2008
• Recall Event ID: 45819
• Product Classification: Battery-Defibrillator - Product Code MKJ
• 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
• For Additional Information Contact: Ms. Amanda Wilson; 732-652-5270
• Manufacturer Reason for Recall: Marketed without a 510K
• FDA Determined Cause: 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

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.