Z-1171-2009

Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and...

Name: Z-1171-2009 Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and...
Creator: Physio Control, Inc.
Published: 2009-02-16
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2009-02-16 / Terminated / root cause: labeling and UDI

FDA source

Physio Control, Inc. began a recall of Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors on 2009-02-16. The reason FDA records is "Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1171-2009
Status: Terminated
Initiated: 2009-02-16
Posted: 2009-04-07
Terminated: 2011-08-17
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.
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
Root cause tag: labeling and UDI
FDA 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 in commerce: TOTAL: 3218 units; 2052 in the US, 1166 internationally
Distribution: Worldwide Distribution
Product codes and lots: 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 code LDD

K881153Class IILifepak 9 Defibrillator and Cardiac MonitorPhysio-Control Corp. / cleared 1988-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)