Recall Z-1567-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The FASTPAK battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Se
| Date | Aug 24, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries. |
| Root cause | Labeling mix-ups |
| Action | On February 27, 2008, the firm sent a "URGENT MEDICAL DEVICE - ACCESSORY RECALL" letter via certified return receipt to their consignees. The letter states the batteries are fully functional 1.0 amp/hour batteries mislabeled as 2.4 amp/hour batteries and that the batteries will provide half the monitoring time and half the number of defibrillation shock as of a 2.4 amp/hour LIFEPAK NiCd battery. Enclosed with the letter is a confirmation sheet for the consignee to indicate the number of recalled batteries they have and fax back to the firm. The firm will send out replacement batteries and th |
| Quantity | 811 batteries |
| Distribution | Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America. |
| FDA record | Open on fda.gov |