- The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
- Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
- The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.
The FDA is concerned that “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.” Those concerns informed a recommendation to avoid using syringes made in China and monitor them closely for faults if they are the only syringes available. The issue does not currently include glass syringes and pre-filled syringes.
As part of the investigation, the FDA is working with “federal partners to further test syringes manufactured in China” and continuing to monitor reports of problems with devices made in the country. Officials also plan to “work with manufacturers to ensure adequate corrective actions are taken” and, if needed, stop syringes made in China from entering the U.S.
The start of the investigation, which FDA linked to “quality issues from recent syringe recalls,” comes two weeks after the agency issued Class I recall notices about disposable syringes sold by Cardinal Health and Fresenius Medical Care. Officials cited medical device reports and “additional complaints” about syringes made at various sites in China as triggers for the investigation.
No manufacturers or specific products are named in the notice about the investigation. The quality issues listed by FDA, such as leaks and changes to the syringe dimensions, are similar to those that led to the recalls by Cardinal and Fresenius but it is unclear exactly what prompted the investigation.