In an April 24 letter to Cardinal Health CEO Steve Mason, the FDA said the company changed from manufacturing its monoject Luer-lock tip syringes and monoject enteral feeding syringes to hiring a China-based manufacturer, Jiangsu Shenli Medical Production, to take over.
The swap resulted in different product dimensions for the syringes, according to the FDA.
“… Since switching to overseas manufacturing,” the letter said, “there have been increases in reported syringe safety issues regarding syringe/infusion pump compatibility resulting in your firm’s ongoing syringe recalls.”
The only FDA-approved syringe from Jiangsu Shenli Medical Production is 5cc Luer lock, but there is evidence the manufacturer also supplied Cardinal Health with 3 mL, 10 mL, and 20 mL piston syringes and control syringes, which Cardinal Health included in convenience kits.
Another manufacturer in China, Jiangsu Caina Medical Co., was also tapped to produce the syringes.
The FDA’s letter said Cardinal Health has opened corrective and preventive actions, including a product audit and a review of in-process and completed private brand conversions from the last three years.
Medline Industries and Sol-Millennium Medical have also received warning letters after the FDA reported the syringe issue is “more widespread than originally known.”
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