Cardinal receives FDA warning letter because of unapproved syringes

Cardinal Health received an FDA warning letter on April 24 for selling convenience kits containing piston syringes not FDA authorized. Violations were discovered during an inspection of its Waukegan, Illinois facility. Cardinal distributed syringes from Jiangsu Shenli Medical Production with notably different characteristics than FDA-cleared ones.

Previously, Cardinal faced scrutiny for recalling disposable syringes due to dimensional changes making them incompatible with certain infusion pumps. FDA actions blocked plastic syringe imports from Jiangsu Shenli.

The warning letter focuses on Cardinal's Monoject luer-lock tip and Monoject enteral feeding syringes. Although FDA cleared a 5 mL luer-lock piston syringe from Jiangsu Shenli, Cardinal sold kits with 3 mL, 10 mL, and 20 mL piston syringes lacking FDA clearance. These kits included control syringes, a significant design change jeopardizing safety or effectiveness.

Cardinal transitioned from self-manufacturing to overseas manufacturing with Jiangsu Caina Medical, leading to increased reported syringe safety issues and ongoing recalls. The FDA cautioned against plastic syringes from Jiangsu Caina and Jiangsu Shenli, issuing import alerts.

Cardinal ceased marketing syringes as compatible with infusion pumps and revised internal policies, awaiting FDA evaluation. The agency requested Cardinal outline actions and plans regarding syringe use with infusion pumps.