Cardinal Health has created an electronic instruction for use (eIFU) for Salem Sump™ products because of reports of breakage in the ARV due to improper use of the device. These changes to the labeling have been made to increase user awareness of how to use the ARV correctly and to inform users of the new warning. Lots manufactured after May 1, 2019 are affected. Recall start date: July 22, 2024 Cardinal Health is issuing an update to the urgent medical device product correction originally issued in July 2024, on all lots of Salem Sump™ product codes listed that were manufactured from August 1, 2020. The purpose of this update is to provide additional guidance on how to properly use the Anti-Reflux Valve (ARV).
RecallTracker