Chinese Plastic Syringes Should be Avoided, FDA Recommends

April 16, 2024

Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid the products altogether.

In updated recommendations released Wednesday, the FDA is telling domestic suppliers to “immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Production Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.”

The agency’s March 18 letter to Jiangsu Shenli Medical Production identified syringes made by the company and distributed in the U.S. that had significant modifications in design that could alter the device’s safety or effectiveness and confirmed such product revisions “constitute a major change or modification to the device’s intended use, for which your firm lacks clearance or approval.”

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