FDA Advises Against Use of China-Made Plastic Syringes after Quality Failure Reports

FDA recently issued a safety communication informing consumers of potential device failures with plastic syringes manufactured in China.

“We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” FDA said in a statement.

Not naming any specific companies, the agency said it had received information about quality issues associated with several Chinese manufacturers of plastic syringes including leaks, breakage, and other problems and recommended that consumers, healthcare providers, and facilities not use syringes manufactured in the country if possible. If a user only has access to syringes manufactured in China, FDA said to continued use as needed until alternative syringes become available, but to closely monitor for leaks, breakage, and other problems. The agency also said it has received Medical Device Reports and other complaints about plastic syringes, including problems after manufacturers changed syringe dimensions.

FDA said it is working with federal partners to test syringes manufactured in China, as well as manufacturers to ensure adequate corrective actions are being taken. If necessary, non-adherence to FDA’s actions may result in the prevention of Chinese-made syringes entering the United States.

The safety communication comes two weeks after the agency issued Class I recall notices to both Cardinal Health and Fresenius Medical care in relation to disposable syringes, listing similar quality issues noted in the statement, such as leaks and changes to syringe dimensions.

The Cardinal recall pertained to its Monoject single use Luer Lock Syringes, which were part of Coviden’s portfolio that the company bought from Medtronic in 2017. In June, Cardinal changed the branding of the syringes, changing it from Coviden to Cardinal Health. The branding, however, changed the dimensions of the syringe, leading to the recall.

The differing dimensions reportedly affected their use with syringe pumps, potentially resulting in pump performance issues like overdose, underdose, delay in therapy, and delays in occlusion alarms. The company has received 15 reports of delayed therapy due to syringe infusion pumps not recognizing syringes, and 13 reports of inaccurate volume/rate dispensing, including some injuries.

Fresenius also saw its recall marked as Class I after it was found that the Sanxin Single Use Sterile Syringes had the potential to leak blood or heparin back or from the syringe. There were also reports of an unknown black material inside the syringe. Use of the syringes, according to FDA, could cause serious adverse health consequences including sepsis and blood loss due to leakage, or risks like incorrect heparin dosage.

Of note, the warning does not currently include glass or pre-filled syringes.

The notice has sparked some companies to issue a statement reiterating that the FDA warning does not impact their products as they are not manufactured in China.

Embecta, BD’s diabetes business spinoff, is one such company which felt the need to clarify its manufacturing location. In a statement, the company noted that it manufactures all of its syringes for worldwide distribution at its Holdrege, Nebraska, facility, according to Shaun Curtis, senior vice president of global manufacturing and supply chain.

“The safety notice issued by the FDA on November 30, 2023, only applies to plastic syringes made in China, and therefore has no impact on the ongoing production or sale of any Embecta syringe products,” he said.

Additionally, the statement said the company is prepared to support a potential influx of customers affected by FDA’s safety communication.

“Our skilled workforce in Nebraska, with its unmatched expertise in high volume syringe manufacturing, is prepared to support any healthcare customers who may be affected by the FDA’s safety communication,” Curtis said.