FDA Medical Device Recalls (openFDA)
BatteryZone, Inc.: 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.
- Recall number
- Z-0524-2008
- 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.
- Status
- Terminated
- Initiated
- 2007-08-24
- Posted
- 2007-12-22
- Terminated
- 2013-07-01
- Reason
- Marketed without 510 (K) approval
- 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
- 118 units
- Distribution
- Nationwide; (primarily police/fire departments)
- Lot, serial or model codes
- All Batteries Part Number: 2L561
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 3006525760
- Firm city
- Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28