FDA Updates Safety Recommendation of Plastic Syringes Made in China

• By: Maureen Carland
• On: 04/10/2024 11:00:57
• In: Quality/Regulatory

The U.S. Food and Drug Administration (FDA) issued updated guidelines for U.S. plastic syringe suppliers, consumers, healthcare providers, and facilities. These guidelines are prompted by potential quality and performance concerns. The FDA advises the following actions until further notice:
1. Transition away from using plastic syringes manufactured by Jiangsu Caina Medical Co Ltd unless absolutely necessary. Expedite this transition process.
2. Avoid using unauthorized plastic syringes manufactured by Jiangsu Shenli Medical Production Co Ltd, with the exception of the 5 mL luer lock syringe, unless their use is deemed absolutely necessary. Begin transitioning away from these syringes immediately.
 
Regarding plastic syringes made in China, the FDA recommends the following steps:
1. Verify the manufacturing location of syringes in use or in inventory by checking labeling, outer packaging, or contacting suppliers or purchasing organizations.
2. Whenever possible, opt for syringes not manufactured in China. Currently, glass syringes, pre-filled syringes, and those intended for oral or topical purposes are excluded from this recommendation.
 
If only Chinese-manufactured syringes are available, Use them as needed but be vigilant for leaks, breakage, and other issues.
 
Promptly report any problems with syringes to the FDA.
 
These measures are put in place to ensure the safety and reliability of syringes in the healthcare system.
 
Staff contact: mcarland@mehca.org