The FDA is advising U.S. healthcare providers and patients to stop using any plastic syringes in their inventories that were made in China, if possible, as it looks into a spate of quality complaints.
In a safety communication issued Thursday, the agency said it’s in the process of collecting and analyzing information about reported issues with China-made syringes, including leaks and breakages. The complaints received to date have reportedly spanned several syringe manufacturers in the country.
“We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance,” the regulator wrote.
So far, the FDA said the issue appears to be confined to standard plastic syringes that are used to inject fluids into or withdraw them from a patient. Glass syringes, pre-filled syringes and needle-less syringes used for oral or topical purposes are excluded from the safety advisory.
The quality-related complaints include some reported as part of recent recalls and in other medical device reports (MDRs) submitted to the FDA, as well as additional complaints linked to certain Chinese manufacturing sites, according to the agency.
In addition to leaks and breakages, other problems have been linked to changes in syringe dimensions—which has been cited as the cause of the recent and ongoing Class I recall of tens of millions Monoject syringes that changed dimensions during their rebranding from Covidien to Cardinal Health.
Those reported issues could affect the performance of the syringes and therefore pose a safety hazard to patients, according to the FDA, which offered as an example the possibility that a faulty syringe might not be able to deliver the correct dose of medication.
To avoid such hazards, the regulator has recommended that healthcare providers and consumers “consider using syringes not manufactured in China.” If that’s not possible, they may continue to use the devices until they can procure an alternative but should keep an eye out for leaking, breakage and other issues.
The FDA said it’s currently monitoring all complaints related to the China-made syringes and is working with “federal partners” to conduct testing. It’s also planning to call on the manufacturers themselves to implement any needed corrective actions—which could include blocking the syringes from entering the U.S. at all, if necessary.
The agency didn’t list any specific Chinese manufacturers of the potentially faulty syringes, nor any of the devices’ sellers, but one medtech maker made sure to distance itself from the warning: In a Thursday evening announcement of its own, BD said the FDA’s recommendations do not apply to any of the syringes it sells.
“Essentially all plastic syringes BD provides to the U.S. health care system are manufactured in the United States in Nebraska and Connecticut,” said Eric Borin, president of the company’s medication delivery solutions business, adding, “BD remains committed to supporting the U.S. health care system and is ready to increase production to help supply those providers who currently purchase syringes impacted by the FDA communication.”