Physio-Control, Stryker is conducting a voluntary correction for specific Infant Child Reduced Energy Electrodes that were manufactured by the electrode manufacturer, Cardinal Health, Inc. Affected electrodes were enclosed in packaging that may have compromised packaging seals. This recall affects Infant Child Reduced Energy Electrodes manufactured between August 2017 through October 2019. These electrodes are designed for use with the LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator. If you prefer speaking to someone call Stryker tech support at 1-800-787-9537 option 2.
Stryker SAFETY NOTICE and CORRECTION
Acknowledgement and Receipt Form - Response is Required
Created 6/11/2020 FDA Link
