Recall Z-0524-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
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.
| Date | Dec 22, 2007 (initiated Aug 24, 2007) |
| Status | Terminated |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.