UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
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On May 8, 2024, Sol-Millennium Medical, Inc. initiated a recall to stop using affected products, which includes unauthorized plastic syringes made in China such as “combined” syringes with needle and syringe components packaged together, low dead space (“LDS”) syringes, luer slip tip syringes, eccentric tip syringes, and syringe accessories.
The FDA recommendations have not changed.
We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available. A timeline and summary of FDA activities is provided in FDA Actions.
Date Issued: March 19, 2024
The U.S. Food and Drug Administration (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.
In November 2023, the FDA informed consumers, health care providers, and health care facilities that the FDA is evaluating the potential for device failures (such as leaks, breakage, and other problems) with plastic syringes manufactured in China, that are used for injecting fluids into, or withdrawing fluids from, the body. We had received information about quality issues associated with several China-based manufacturers of syringes. The issue does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
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.
Recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities (Updated April 10, 2024)
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 plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd 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.
Device Description
Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body and can be used in a variety of clinical and home health settings. Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.
Potential Syringe Failures
The FDA will continue our extensive efforts to evaluate problems with plastic syringes manufactured in China, including facility inspections, examining products at the border and detaining them as appropriate, laboratory testing of syringes, and working with manufacturers, when applicable, to ensure adequate corrective actions are taken. We will also continue to monitor all available sources of data for reports of problems with syringes manufactured in China, such as leaks, breakage, and other problems after manufacturers made changes to the syringe dimensions. These 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.
FDA Actions (As of May 9, 2024)
The FDA believes that the supply and manufacturing capacity of plastic syringes made in countries other than China, including domestic manufacturing, is adequate to support current health care demand.
We will continue to work with stakeholders, including other federal agencies, medical device manufacturers, and health care organizations to help ensure the safety of syringes being used in the U.S. In addition, we will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
| Date | Actions |
|---|---|
| April 25, 2024 | The FDA updated this communication to announce a warning letter was issued to Cardinal Health that describes violations related to the sale and distribution of unauthorized plastic syringes made in China and quality system regulations for syringe products. |
| April 10, 2024 |
The FDA updated this communication to announce Jiangsu Shenli Medical Production Co. Ltd. was added to an additional import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States. The FDA also updated recommendations for U.S. suppliers of plastic syringes, consumers, health care providers and facilities to state: Until further notice and because of potential quality and performance issues, the agency recommends that U.S. suppliers of plastic syringes, consumers, health care providers and facilities immediately transition away from using all models of plastic syringes (including 5 mL luer lock syringes) manufactured by Jiangsu Shenli Medical Production Co. Ltd., unless use of these syringes is absolutely necessary until you can complete the transition. |
|
April 3, 2024 and |
The FDA updated this communication to announce Jiangsu Caina Medical Co. Ltd. was added to import alert for not meeting device quality system requirements, to prevent all plastic syringes by this manufacturer from entering the United States. The FDA updated this communication to announce Jiangsu Shenli Medical Production Co. Ltd. was added to import alert to prevent unauthorized plastic syringes from entering the United States. |
| March 19, 2024 |
The FDA issued this communication to provide 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. This communication is an update from the November 30, 2023 Safety Communication. The FDA also issued a CDRH Statement: FDA Provides Update on Plastic Syringes Made in China, Issues Warning Letters Related to Violative Products. |
Reporting Problems to the FDA
If you think you had a problem with a syringe, or any medical device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
If you are experiencing supply issues for syringes, or other devices, you may contact the FDA about a medical device supply chain issue. Reporting supply chain issues to the FDA helps inform actions to prevent shortages and protect patient health.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.