Two Additional Chinese Manufacturers’ Syringes Blocked From Entering US

The FDA has imposed import alerts on two additional Chinese manufacturers of plastic syringes, preventing these products from entering the US, and is warning healthcare practitioners as well as consumers to transition away from the devices.

Now under import alert are Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group “for not meeting device quality system requirements,” the FDA said in its announcement. Issues with the syringes include leaks and breakage.

The issue began in November when the agency warned that it was considering preventing the syringes from entering the US while it investigated. Then, in March, the agency sent Warning Letters to three manufacturers of plastic syringes — Jiangsu Shenli Medical Production, Medline Industries, Sol-Millennium Medical — over approval, quality and safety concerns.

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