FDA cautions people against made-in-China plastic syringes

It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements, but it’s not every day that the head of the Center for Devices and Radiological Health (CDRH) issues a statement warning consumers not to use such products. On 19 March, CDRH Director Jeff Shuren said the agency had sent Jiangsu Shenli Medical, Sol-Millennium Medical, and Medline Industries warning letters for failing to meet quality system requirements and told the public to avoid using such syringes unless there are no other alternatives.

“The FDA has continued its extensive efforts to evaluate problems with plastic syringes made in China, including facility inspections for Medline Industries, LP and Sol-Millennium Medical, Inc., examining and detaining products at the border, laboratory testing of syringes, and working with applicable manufacturers to ensure adequate corrective actions are taken,” Shuren said in a statement. “Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known.”

FDA initially issued a warning to the public in November. After further investigation, the agency has issued an updated warning stating that the problem is more widespread than expected and that consumers should avoid using Chinese-made plastic syringes. The warning does not apply to glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.

FDA recommended that US suppliers, consumers and healthcare providers transition away from plastic syringes manufactured by Jiangsu Shenli Medical Production and Jiangsu Caina Medical. Jiangsu Caina Medical’s 5 mL luer lock syringes are still okay to use.

“As this is an ongoing evaluation, for all other plastic syringes made in China, the agency’s recommendations remain unchanged from our November 2023 safety communication,” said Shuren. “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.

“To determine if your syringes were made in China, confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization,” he added.

FDA said it isn’t concerned the issue will lead to a supply chain problem because sufficient domestic and other international manufacturers can supply the plastic syringes.

On 18 March, FDA sent warning letters to Jiangsu Shenli Medical, Sol-Millennium Medical, and Medline Industries citing them for selling and distributing unauthorized plastic syringes in the US that were made in China without agency clearance or approval. Sol-Millennium and Medline were also warned that the agency found quality system violations at their facilities.

“In addition, the FDA is actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co. Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP,” said Shuren. “The FDA is aware of performance testing that showed unexpected and unexplained failures with several Jiangsu Caina plastic syringes. The FDA evaluation is ongoing and we will take additional steps as appropriate.” RAPS.org