FDA Announces Recall of Unauthorized Plastic Syringes

SyringeImage via Pixabay

WASHINGTON, D.C. — On Friday, the FDA announced a recall initiated by Merit Medical Systems, Inc. after Jiangsu Shenli Medical Production Co Ltd. issued a recall for its unauthorized plastic syringes. Merit Medical Systems uses these syringes in multiple kits.

The FDA’s recommendations remain unchanged as it continues to evaluate issues with syringes made in China. The agency advises transitioning away from using plastic syringes from four specific Chinese manufacturers unless absolutely necessary. These manufacturers are Jiangsu Caina Medical Co Ltd., Jiangsu Shenli Medical Production Co Ltd., Shanghai Kindly Enterprise Development Group Co Ltd., and Zhejiang Longde Pharmaceutical Co Ltd.

The FDA stresses the importance of checking the manufacturing location of syringes by reviewing labeling, outer packaging, or contacting suppliers. If alternatives are available, healthcare providers should use syringes not made in China. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included in the recall.

For those who must continue using Chinese-manufactured syringes, the FDA recommends close monitoring for leaks, breakage, and other problems. Any issues should be reported to the FDA immediately.

This action aims to address potential quality and performance concerns with these syringes. The FDA will keep the public informed as new information becomes available.

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