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 Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an ex Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an ex
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
All batteries with lot code 0624.
Products Sold
All batteries with lot code 0624.
Physio Control, Inc. is recalling FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA U due to Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.
Recommended Action
Per FDA guidance
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 the consignee is to then send back the mislabeled batteries. If there are any questions, contact the technical support group at 1-800-442-1142 - option 5 or visit www.physio-control-notices.come/fastpak.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026