Devices

Device Recall FASTPAK

Model / Serial
All batteries with lot code 0624.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.
Product Description
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 external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity. || Battery part number 9-10424-18. Sold with LIFEPAK defibrillators and also sold separately.
Manufacturer
Physio Control, Inc.
1 Event
- Recall of Device Recall FASTPAK

Manufacturer

Physio Control, Inc.

Manufacturer Address
Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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