FDA Medical Device Recalls (openFDA)
Physio Control, Inc.: Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
- Recall number
- Z-1171-2009
- Recalling firm
- Physio Control, Inc.
- Product
- Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
- Status
- Terminated
- Initiated
- 2009-02-16
- Posted
- 2009-04-07
- Terminated
- 2011-08-17
- Reason
- Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
- Root cause
- Other
- Action
- 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.
- Quantity
- TOTAL: 3218 units; 2052 in the US, 1166 internationally
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K881153"]
- PMA numbers
- not on file
- Product code
- LDD
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28