Since November of 2023, the FDA has informed consumers, health care providers, and health care facilities that there are potential device failures with plastic syringes that were manufactured in China. These syringes are used to inject fluids into, or withdraw fluids from the body. The potential failures included leaks and breakage, alongside other unlisted problems.
In March of 2024, the FDA issued warning letters to: Jiangsu Shenli Medical Production Co. Ltd., Medline Industries, LP, and Sol-Millennium Medical, Inc. These letters highlighted the violations relating to sale and distribution of unauthorized plastic syringes made in China that haven't been cleared or approved by the FDA.
On April 10, 2024 the FDA stated that the plastic syringes manufactured by Jiangsu Caina Medical Co Ltd and Jiangsu Shenli Medical Production Co Ltd are to be transitioned out of use unless absolutely necessary until the transition can be completed. This statement is until further notice due to potential quality and performance issues.
The FDA also recommends using syringes not manufactured in China if possible. Locations that only have Chinese manufactures syringes can continue to use them until alternative syringes are available, but to continually check them for leaks and breakage.
The last reported update came on April 24, 2024. The FDA issued a warning letter to Cardinal Health describing "violations related to the sale and distribution of unauthorized plastic syringes made in China and quality system regulations for syringe products."
We will update this story when more information is available.
Source: fda.gov