FMS - FDA probing plastic syringes made in China for potential leaks breakages

2023-11-30 14:59:50 ET

The U.S. Food and Drug Administration (FDA) on Thursday said it was assessing plastic syringes made in China for potential device failures such as leaks or breakages.

The FDA added that it was aware of quality issues from recent syringe recalls, medical device reports, and additional complaints about syringes made at various manufacturing sites in China.

"The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into, or withdrawing fluids from, the body. At this time, the issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes," the regulator said in a statement .

While the FDA continues its evaluation, it recommends consumers, health care providers and facilities check the manufacturing location of the syringes they use or have in their inventory by reviewing the labeling or packaging.

Syringes in general have been under some scrutiny this month. The FDA last week alerted healthcare providers against using Cardinal Health's ( CAH ) Monoject syringes. Meanwhile, Fresenius Medical Care ( FMS ) recently recalled its Sanxin single-use sterile syringes for leakage issues.

"The FDA is working with federal partners to further test syringes manufactured in China. The FDA 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," the regulator added.

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