Physio Control, Inc. Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
Brand
Physio Control, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Physio Control, Inc. is recalling Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPA due to Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
Recommended Action
Per FDA guidance
Recalling firm sent Urgent Medical Device Recall letters, dated 2/2009, advising customers to discontinue use of the listed sterilization methods and to remove them from service since there is no sterilization method that can be supported by current data. They are to use the enclosed form to identify and confirm if they have the listed products and follow the instructions on the form for returning information to the firm.
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