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: