Cardinal Health Gets Warning Letter Over Defective Monoject Syringes

FDA never approved recent changes in manufacturers and new dimensions for the syringe sizes, which led to a massive Monoject syringe recall earlier this year

Federal regulators have issued a warning letter to Cardinal Health after facility inspections found the company was marketing and distributing unapproved, misbranded syringes.

The U.S. Food and Drug Administration (FDA) issued the warning letter to Cardinal Health on April 24 over the distribution of its Monoject syringes. The letter comes after the FDA issued a recall for all Cardinal Monoject Luer-lock and Enteral syringes earlier this year, due to incompatibility problems with infusion and pain management pumps.

Investigators now understand this issue stemmed from Cardinal switching manufacturing operations overseas.

Later, Cardinal had to remove 28 million Monoject syringes from the U.S. market following reports of problems when the syringes were used with infusion pumps, causing the devices to malfunction and lead to overdoses, under-doses, and delays in therapy.

Monoject Luer-lock tip syringes are used to inject fluids into or withdraw fluids from the body. Monoject Enteral Feeding Syringes are used to deliver fluids, feed patients, or deliver medications to a patient’s feeding tube.

Inspectors Finds Marketing and Manufacturing Problems

A December 2023 inspection of Cardinal’s facility in Waukegan, Illinois determined there were several violations of FDA rules, including importing and disturbing unbranded and unapproved syringes, as well as manufacturing syringes in unsterile environments.

The syringes are manufactured by Jiangsu Shelli Medical Production Co. Ltd. in China and are considered medical devices under the Federal Food, Drug, and Cosmetic Act and require FDA review and approval.

Under FDA regulations, anything used to diagnose disease, treat conditions, cure diseases, or prevent disease is considered a medical device and must adhere to FDA regulations. This includes syringes.

Investigators determined Cardinal did not obtain premarket approval for the products and did not notify the FDA of their intent to sell the products on the U.S. market. The FDA also indicated the syringes did not comply with good manufacturing practices. The company did not follow sterile manufacturing conditions and changed the dimensions of the product when it changed manufacturing facilities overseas to China.

The warning letter noted several problems with the manufacturing process, including changes to product dimensions, which can lead to compatibility issues with syringe pumps, patient-controlled analgesia pumps, and enteral syringe feeding pumps. This can cause medications and fluids to be delayed to patients or the wrong medications or fluids to be delivered, leading to serious health consequences.

Additionally, the warning letter indicates the switch in manufacturing locations and changes in the design of the syringes occurred without FDA approval.

The devices in question are syringe kits including 3 mL, 10 mL, and 20 mL piston syringes and control syringes manufactured by Jiangsu Shelli Medical Production Co. Ltd. The only Jiangsu piston syringe currently approved by the FDA is the Luer-lock string. No other size piston syringes are approved.

Cardinal must update the FDA in writing about what plans the company intends to take regarding the compliance of the issues noted in the warning letter and how it will address safety and syringe incompatibility issues.

Failing to comply with the warning letter can result in violations and regulatory action being initiated by the FDA. Regulatory action can include seizure, injunction, and civil money penalties.