Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure Pack with Split Drape, Port Insertion Pack, and Procedure Pack

Date: 19/08/2021

Product Names: Custom Convenience Kits containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leaderflex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure Pack with Split Drape, Port Insertion Pack, and Procedure Pack
Product Codes: See Recall Database Entry
Model Numbers: AMS-9041CP, AMS-9046CP-1, AMS8939A, AMS9957A, and AMS12149
Distribution Dates: January 23, 2020 to October 19, 2020
Devices Recalled in the U.S.: 9,378
Date Initiated by Firm: August 19, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/aligned-medical-solutions-doing-business-windstone-medical-packaging-inc-recalls-custom-convenience