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Terminated

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.

FDA Recall Z-0523-2008 · Posted 2007-12-22

Recalling FirmBatteryZone, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-08-24
Date Terminated2013-07-01
Product Quantity24 units

Reason for Recall

Marketed without 510 (K) approval

Firm 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.

Root Cause

No Marketing Application

Distribution Pattern

Nationwide; (primarily police/fire departments)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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