life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps.,OEM P/N: 9141-001,Mfg for Battery Zone, Inc; Mfg by Nordix, Inc.
FDA Recall Z-0524-2008 · Posted 2007-12-22
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Recalling FirmBatteryZone, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-08-24
Date Terminated2013-07-01
Product Quantity118 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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