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FDA launches safety investigation into syringes manufactured in China

December 1, 2023

The Food and Drug Administration (FDA) is investigating the quality of plastic syringes manufactured in China amid performance and safety concerns, including their ability to deliver the correct dose of medication when used alone or with other medical devices.

In a safety announcement, the FDA said it is collecting and analyzing data to evaluate syringes from several manufacturers in China following reports of device failures, including leaks, breakage and other problems.

“Syringes are, of course, such an important tool for us, as pediatricians, to prevent and treat illnesses in children,” said James D. Campbell, M.D., M.S., FAAP, vice chair of the Committee on Infectious Diseases. “Their quality is critical, and we are glad to see that the FDA is carefully reviewing these reports of potential device failures.”

The FDA is working with federal partners to test syringes made in China. The agency announced plans to work with manufacturers to ensure adequate corrective actions are taken, which may include preventing syringes made in China from entering the United States.

At this time, the issue does not include glass syringes, prefilled syringes or syringes used for oral or topical purposes.

While the FDA evaluates the syringes, clinicians are encouraged to do the following:

  • Check the manufacturing location for syringes you use or have in your inventory by reading the labeling, outer packaging or contacting your supplier or group purchasing organization.
  • Consider using syringes not manufactured in China, if possible.
  • If you only have syringes manufactured in China, continue to use them as needed until you are able to use alternative syringes. Closely monitor syringes for leaks, breakage and other problems.
  • Report any issues with syringes to the FDA through the MedWatch Adverse Event Reporting Program.

The syringes being investigated often are used to inject fluids into or withdraw fluids from the body. Some syringes also may be used with infusion pumps to deliver fluids into the body in a controlled manner.

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