Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect

Date: 11/09/2021

Product type: Medical Device

• 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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program