In March 2024 the US Food and Drug Administration (FDA) issued a safety communication regarding their ongoing evaluation of quality and performance issues related to plastic syringes made in China, following their initial publication of this signal in November 2023. The FDA continues to update this safety communication as new information becomes available, including details of manufacturers that are potentially affected.
The FDA has identified non-compliances relating to quality system regulations for syringe products, quality issues and performance testing failures.
We have initiated a post-market review of the plastic syringes included in the Australian Register of Therapeutic Goods (ARTG) including those identified by the FDA.
Background of the review
Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body and can be used in a variety of clinical and home health settings. Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.
The plastic syringes identified by the FDA may have quality issues, such as leaks, breakage, and other problems that occur after manufacturers made changes to syringe dimensions. These quality issues may affect the performance and safety of the syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.
Information for consumers and healthcare professionals
Any other updates on the post market review, and syringes impacted by these issues, will be published on this page as further information becomes available.
Any recall actions undertaken will also be published on our recall actions database, the System for Australian Recall Actions (SARA).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).