FDA Evaluates China-made Plastic Syringes For Potential Device Failures

(RTTNews) - The U.S. Food and Drug Administration said Thursday that it is evaluating plastic syringes made in China for potential device failures, such as leaks, breakage, and other problems.

However, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes, the FDA said.

Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body and can be used in a variety of clinical and home health settings. Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.

The FDA said it is aware of quality issues from recent syringe recalls, Medical Device Reports, and additional complaints about syringes made at various manufacturing sites in China.

Quality issues reported have included leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. The quality issues may affect the performance and safety of the syringes including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.

The FDA noted that it plans to work with manufacturers to ensure adequate corrective actions are taken, and, as necessary, may prevent syringes made in China from entering the United States.

Meanwhile, Becton, Dickinson and Co.(BDX) or BD said that the FDA safety notice does not apply to any BD syringes. Essentially all plastic syringes BD provides to the U.S. health care system are manufactured in the United States in Nebraska and Connecticut.

BD said it 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.