Devices

Device Recall Internal Sterilizable Paddles and Handles without discharge control

Model / Serial
Internal Defibrillation Handles without discharge control: Part Numbers 800441-03 thru 800441-06 Internal Defibrillation Electrodes (threaded end): Part Numbers: 802154-10 thru 802154-19 Sterilization labeling affects ALL part numbers referenced above.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
Manufacturer
Physio Control, Inc.
1 Event
- Recall of Device Recall Internal Sterilizable Paddles and Handles without discharge control

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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