life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage
FDA device recall Z-0523-2008 · posted 2007-12-22 · Terminated
Recall details
- Recalling firm
- BatteryZone, Inc.
- Reason for recall
- Marketed without 510 (K) approval
- Action taken
- 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
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 24 units
- Distribution
- Nationwide; (primarily police/fire departments)
- Date initiated
- 2007-08-24
- Date posted
- 2007-12-22
- Date terminated
- 2013-07-01
- Location
- Branchburg, NJ
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