Date: 10/27/2021
Product type: Defect, Medical Devices
Company Announcement Date: October 20, 2021
FDA Publish Date: October 27, 2021
Product Type: Medical Devices
Reason for Announcement: Potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe
Company Name: Windstone Medical Packaging dba Aligned Medical Solutions
Brand Name: Cardinal Health’s Monoject™
Product Description: Flush Prefilled Saline Syringes