Problem-Laden Syringes’ Marketing Earns Cardinal Health FDA Warning Letter

Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production.

In December 2023, the FDA issued a Safety Communication warning of leaks, breakage and other problems with Jiangsu Shenli plastic piston syringes, urging users to check the manufacturing location of syringes and not to use them.

The April 24 Warning Letter, issued following a Dec. 11-20, 2023, inspection, states that the control kits are adulterated because Cardinal does not have an approved PMA or an investigational device exemption. Cardinal also did not notify the FDA that it planned to introduce the devices into commercial distribution causing them to be misbranded.

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