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Terminated

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

FDA Recall Z-1171-2009 · Posted 2009-04-07

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2009-02-16
Date Terminated2011-08-17
Product QuantityTOTAL: 3218 units; 2052 in the US, 1166 internationally

Reason for Recall

Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K881153LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITORPhysio-Control Corp. · 1988-07-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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