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Latest Update on FDA’s Evaluation of Plastic Syringes Made in China for Potential Device Failures
The FDA is providing an update on our ongoing evaluation of quality and performance issues related to plastic syringes made in China, and announcing additional recommendations and actions the FDA is taking to address these issues.
On March 18, 2024, the 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.
At this time, the FDA is providing additional recommendations to our November 2023 safety communication. Until further notice and because of potential quality and performance issues, the agency recommends that U.S. suppliers, consumers, and health care organizations immediately transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co. Ltd and unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd (which includes all models other than the 5 mL luer lock syringe), unless absolutely necessary until the transition is complete. As this is an ongoing evaluation, for all other plastic syringes made in China, the agency’s recommendations remain unchanged from our November 2023 safety communication. Continue to use them as needed only until you are able to transition to alternatives and closely monitor for leaks, breakage, and other issues, and report any problems to the FDA. This issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes. To determine if your syringes were made in China, confirm the manufacturing location by reviewing the labeling, outer packaging, or contacting the supplier or group purchasing organization.
Questions?
If you have questions about this communication, contact the Division of Industry and Consumer Education.
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