 
Today, the U.S. Food and Drug Administration (FDA) issued warning letters that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. to the following three entities:
- Jiangsu Shenli Medical Production Co. Ltd. (China-based manufacturer of plastic syringes)
- Medline Industries, LP (firm marketing and distributing plastic syringes made in China within the U.S.)
- Sol-Millennium Medical, Inc. (firm marketing and distributing plastic syringes made in China within the U.S.)
The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also concern violations related to quality system regulations for syringe products. The FDA expects these entities to fully address the violations described in the warning letters. In addition, we are actively evaluating quality issues and performance testing failures with plastic syringes made by Jiangsu Caina Medical Co Ltd, a China-based manufacturer cited in the warning letter issued to Medline Industries, LP. The FDA will take additional steps as appropriate.
We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the public informed as new or additional information becomes available.
Recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities
Until further notice and because of potential quality and performance issues,
- Immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co Ltd, unless use of these syringes is absolutely necessary until you can complete the transition.
- Immediately transition away from using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd, which includes all models other than the 5 mL luer lock syringe, unless use of these syringes is absolutely necessary until you can complete the transition.
For all other plastic syringes made in China, while the FDA’s evaluation remains ongoing, we continue to recommend the following:
- Check the manufacturing location for syringes you use or have in your inventory by reviewing the labeling, outer packaging, or contacting your supplier or group purchasing organization.
- Use syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for oral or topical purposes are not included.
- If you only have syringes manufactured in China, then continue to use them as needed until you are able to use alternative syringes and closely monitor for leaks, breakage, and other problems.
- Report any issues with syringes to the FDA
Questions?
If you have questions about this communication, contact the Division of Industry and Consumer Education.
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