Evaluating Plastic Syringes Made in China for Potential Device Failure
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Latest Update: August 16, 2024
Following the removal of piston syringes produced by Zhejiang Longde Pharmaceutical Co., Ltd. from Import Alert 89-04, our guidance remains unchanged. We still advise:
- Opt for syringes not sourced from China whenever feasible. Glass syringes, pre-filled syringes, or those intended for topical use remain unaffected.
- If only Chinese-manufactured syringes are available, you may continue using them but should remain vigilant for any signs of leaks, fractures, or other issues.
We are committed to investigating the issues associated with syringes from China and will keep the public updated as new information emerges.
A detailed timeline and summary of actions taken on this matter, including any recalls, can be found in the FDA Actions.
Issued on: March 19, 2024
The U.S. Food and Drug Administration (FDA) is releasing further insights regarding our continuing examination of quality and operational issues tied to plastic syringes coming from China. Additional recommendations and actions have been announced.
Back in November 2023, we informed various stakeholders that we were assessing the potential for device malfunctions—things like leaks and breakage—with Chinese-manufactured plastic syringes used for medical purposes. The problem does not pertain to glass, pre-filled syringes, or other topical applications.
On March 18, 2024, the FDA dispatched warning letters highlighting compliance issues regarding the sale and distribution of unapproved Chinese plastic syringes to three companies. Specifically, the letters targeting Medline Industries, LP and Sol-Millennium Medical, Inc. pointed out regulatory violations related to their syringe products.
We remain vigilant about potential inconsistencies in quality and performance from certain models of Chinese-manufactured syringes. Our assessment is ongoing, and we will provide timely updates to the public as new data arises.
Recommendations for Suppliers, Consumers, and Healthcare Facilities (Updated August 16, 2024)
Due to potential quality challenges, we recommend the following:
- Transition away from syringes produced by specific Chinese manufacturers unless absolutely necessary. Affected suppliers include:
- Jiangsu Caina Medical Co., Ltd.
- Jiangsu Shenli Medical Production Co., Ltd.
- Shanghai Kindly Enterprise Development Group Co., Ltd.
- For enteral syringes manufactured by Jiangsu Shenli, use them only when necessary until a transition to a different supplier can be completed.
- Do not halt the use of all enteral syringes made in China at this time.
For remaining plastic syringes made in China, our current recommendations are:
- Verify the manufacturing location of the syringes in your inventory by checking labels or contacting your supplier.
- Whenever possible, use syringes not made in China. Glass, pre-filled, and topical syringes are exempt.
- Continue using Chinese-manufactured syringes if no alternatives are available but remain vigilant for signs of failure.
- Report issues with syringes to the FDA.
Device Overview
Syringes are essential for administering fluids into or extracting them from the body, serving in various clinical and home care environments. They can also be paired with infusion pumps for controlled fluid delivery.
Enteral syringes aid in supplying nutritional substances to patients incapable of oral intake. They can also administer medications orally or through a feeding tube.
Potential Syringe Failures
The FDA is actively inspecting the quality concerns around plastic syringes produced in China, conducting facility inspections, product inspections at entry points, and laboratory testing. These efforts aim to ensure manufacturers follow through on necessary corrective measures. We remain dedicated to monitoring all available data regarding syringe-related incidents, including leaks and breakages.
FDA Initiatives
The FDA asserts that other manufacturers—particularly those outside China—possess sufficient capacity to meet healthcare demands. We are engaging with various stakeholders to maintain safe usage standards for syringes across the U.S.
Related Updates and Actions
| Date | Actions |
|---|---|
| July 18, 2024 | The FDA announced a new warning letter issued to Jiangsu Shenli Medical for quality violations. This led to a broader import alert for their enteral syringes. |
| June 20, 2024 | The FDA noted a recall from Cardinal Health involving Jiangsu Shenli syringes. |
Reporting Issues to the FDA
If you encounter problems with a syringe or any medical device, please report it using the MedWatch system.
Healthcare staff at affected facilities should adhere to their organization’s reporting guidelines. For supply chain concerns, reach out to the FDA to alert them of the issue.
Inquiries?
If you have any questions, feel free to contact the Division of Industry and Consumer Education (DICE) via email or call at 800-638-2041 or 301-796-7100.