FDA Recommends U.S. Healthcare Facilities Stop Using Plastic Syringes from two Chinese Manufacturers

The U.S. Food and Drug Administration (FDA) announced this week that its ongoing investigation of plastic syringes for potential failures has found that the use of the more widespread than it thought and recommends that healthcare facilities immediately stop using them.

“Continue to use them as needed only until you are able to transition to alternatives and closely monitor for leaks, breakage, and other issues, and report any problems to the FDA,” says Jeff Shuren, MD., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) in a March 19 statement.

The plastic syringes could leak, break or deliver the wrong dosages of medications when used alone or with medical devices such as infusion pumps, says the FDA. The agency noted in at least one of the three warning letters it sent on March 18 that the syringes were used in operating rooms and other healthcare settings. The letters were sent to Jiangsu Shenli Medical Production Co., the China-based manufacturer of the syringes, as well as Medline Industries and Sol-Millennial Medical, which market and distribute them in the United States.

The FDA issued its first warning about the issue of using unauthorized syringes made in China that the agency hasn’t approved in November 2023. Glass syringes, pre-filled syringes and syringes used for oral or topical purposed are not a subject of the FDA’s investigation.

”In addition, we are actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co Ltd…,” says Dr. Shuren. “The FDA will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing.”

The FDA recommends that healthcare facilities immediately stop using plastic syringes made by Jiangsu Caina Medical Co. and Jiang Shenli Medical Production Co., unless the syringes absolutely must be used until different ones can be obtained while monitoring their use closely for leaks, breakage or other problems.

Anyone with issues can use this form to report them to the FDA. OSM