Issue date: March 19, 2024
The U.S. Food and Drug Administration (FDA) provides an update on our ongoing evaluation of quality and performance issues related to plastic syringes manufactured in China and announces additional information. recommendations and the actions the FDA is taking to address these issues.
In November 2023, the FDA informed consumers, healthcare providers, and healthcare facilities that the FDA is evaluating the potential for device failures (such as leaks, breakages, and other problems) with plastic syringes made in China, which are used to inject or withdraw liquids. , the body. We had received information about quality issues associated with several China-based syringe manufacturers. The issue does not include glass syringes, prefilled syringes, or syringes used for oral or topical use.
On March 18, 2024, the FDA issued warning letters describing violations related to the sale and distribution of unauthorized plastic syringes manufactured in China that have not been authorized or approved by the FDA for sale or distribution in the United States. USA to the following three entities:
The warning letters for Medline Industries, LP and Sol-Millennium Medical, Inc. also address violations related to quality system regulations for syringe products. The FDA expects these entities to fully address the violations described in the warning letters. Additionally, we are actively evaluating quality issues and performance testing failures with plastic syringes manufactured by Jiangsu Caina Medical Co Ltd, a China-based manufacturer cited in the warning letter sent to Medline Industries, LP. The FDA will take additional action as appropriate.
We remain concerned that certain syringes manufactured in China do 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 US plastic syringe suppliers, consumers, providers, and healthcare facilities.
Until further notice and due to potential quality and performance issues,
- Immediately stop using plastic syringes manufactured by Jiangsu Caina Medical Co. Ltdunless the use of these syringes is absolutely necessary until you can complete the transition.
- Immediately stop using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltdwhich includes all models except 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 manufactured in China, while the FDA evaluation continues, we continue to recommend the following:
- Verify the manufacturing location of syringes you use or have in your inventory by checking labeling, outer packaging, or by contacting your supplier or group purchasing organization.
- Use syringes that are not made in China, if possible. Glass syringes, prefilled syringes, and syringes used for oral or topical purposes are not included at this time.
- If you only have syringes made in China, continue using them as needed until you can use alternative syringes and monitor closely for leaks, breaks, and other problems.
- Report any problems with syringes to the FDA.
Description of the equipment
A syringe is generally used to inject or withdraw fluid from the body and can be used in a variety of clinical and home health settings. Some syringes can also be used with infusion pumps to deliver fluids to the body in a controlled manner.
Possible syringe failures
The FDA will continue our extensive efforts to evaluate problems with plastic syringes manufactured in China, including facility inspections, product examination at the border and detention as appropriate, laboratory testing of syringes, and working with manufacturers, where appropriate, to ensure appropriate corrective actions. are taken. We will also continue to monitor all available data sources for reports of problems with Chinese-made syringes, such as leaks, breakages, and other problems after manufacturers made changes to syringe dimensions. These quality issues can affect the performance and safety of 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
The FDA will continue to work with stakeholders, including other federal agencies, medical device manufacturers, and healthcare organizations to help ensure the safety of syringes used in the U.S. Additionally, we will continue our efforts to evaluate issues. with syringes made in China. and keep the public informed as new or additional information becomes available.
Report problems to the FDA
If you think you have had a problem with a syringe or any medical device, the FDA recommends that you do so. report the problem via the MedWatch voluntary reporting form.
Health care personnel employed by facilities subject to the FDA User Facility Reports Requirements must follow the reporting procedures established by your facility.
If you have problems supplying syringes or other devices, you can 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, please email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
