(Reuters) – The U.S. Food and Drug Administration (FDA) said on Thursday it is looking into reports of leaks, breakages and other quality problems with plastic syringes manufactured in China.
The agency was conducting further investigations along with federal partners and may prevent plastic syringes made in China from entering the U.S. market, if necessary, it said.
The probe comes after the changes made to the syringe dimensions during production led to recent recalls and complaints registered to the health regulator about syringes made at various manufacturing sites in China.
The agency advises patients and health providers, such as hospitals, to consider using syringes made outside of China during its investigation.
The potential device failures could affect health providers’ ability to deliver the correct dose of medication when used alone or with other medical devices, such as infusion pumps, the health regulator said, adding it would work with manufacturers to make sure corrective actions were taken.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shweta Agarwal)
