Z-0524-2008

life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V...

Name: Z-0524-2008 life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V...
Creator: BatteryZone, Inc.
Published: 2007-08-24
License: https://open.fda.gov/license/

BatteryZone, Inc. / initiated 2007-08-24 / Terminated

FDA source

BatteryZone, Inc. began a recall of 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... on 2007-08-24. The reason FDA records is "Marketed without 510 (K) approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0524-2008
Status: Terminated
Initiated: 2007-08-24
Posted: 2007-12-22
Terminated: 2013-07-01
Recalling firm: BatteryZone, Inc.
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Marketed without 510 (K) approval
FDA root cause: 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: 118 units
Distribution: Nationwide; (primarily police/fire departments)
Product codes and lots: All Batteries Part Number: 2L561

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)