A hand holding a Chinese made syringe

The U.S. Food and Drug Administration (FDA) is currently assessing potential device failures associated with plastic syringes manufactured in China. These evaluations specifically target concerns related to leaks, breakage, and other performance issues observed in plastic syringes employed for injecting or withdrawing fluids from the body. It’s important to note that the issue at hand does not encompass glass syringes, pre-filled syringes, or those designated for oral or topical use.

Upon learning about quality issues with multiple Chinese syringe manufacturers, the FDA has expressed concerns. These concerns focus on the consistency and adequacy of specific syringes manufactured in China, addressing both the quality and performance of the syringes.

Guidelines for Consumers, Health Care Providers, and Facilities

During the ongoing evaluation of plastic syringes made in China, the FDA advises the following:

Verify the manufacturing origin of syringes in use or present in inventory by reviewing labeling, outer packaging, or consulting with suppliers or group purchasing organizations.

Consider utilizing syringes not sourced from China, if feasible. This recommendation presently excludes glass syringes, pre-filled syringes, or those intended for oral or topical use.

If you only have access to syringes manufactured in China, go ahead and use them as necessary. However, be sure to closely monitor for potential issues such as leaks, breakage, or any other performance concerns during usage.

Promptly report any encountered problems with syringes to the FDA.

Device Description

Syringes are widely used in clinical and home healthcare settings. They play a crucial role in injecting or withdrawing fluids from the body. This versatile tool finds applications in various medical contexts. Some syringes are also compatible with infusion pumps for controlled fluid delivery into the body.

Ensure verification of the manufacturing origin of syringes in use or present in inventory.

Potential Syringe Failures

To date, the FDA has been informed of quality issues stemming from recent syringe recalls, Medical Device Reports (MDRs), and additional complaints concerning syringes manufactured at various sites in China. Reported quality issues have encompassed leaks, breakage, and other problems that emerged subsequent to manufacturers altering syringe dimensions. These issues possess the potential to impact syringe performance and safety. They could affect the syringe’s ability to deliver accurate medication doses. This holds especially true when healthcare professionals use the syringe independently or in conjunction with other medical devices like infusion pumps.