Post-market review of plastic syringes

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.

For further information about ARTG entries which have been cancelled and/or suspended refer to the Outcomes and actions below.

Background

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.

Overview

As part of the review, we required all sponsors of plastic syringe devices included in the ARTG, that are produced by the manufacturers identified in the signal, to provide information about their products, including:

• labelling information including the Instructions for Use (IFU)
• evidence to support design and construction according to safety requirements
• evidence of testing conducted by the manufacturer
• the manufacturer’s risk assessment and risk mitigation strategies
• all domestic and international incidents, adverse events, complaints, and any investigations undertaken, and corrective actions made as a result of these investigations.

Manufacturers of medical devices must ensure they consistently meet safety, performance, and quality requirements.

Plastic syringes produced by manufacturers other than those identified in the signal, are not subject to the current review.

Outcomes and actions

The post-market review is ongoing. We will update this page as new information becomes available.

A number of ARTG entries have been suspended for a period of 6 months. This allows the sponsor and manufacturer time to address issues identified during the review.

While a device is suspended, it cannot be supplied in Australia during the period of the suspension.

Table 1 outlines the current status of the devices included in the review.

Note
An ARTG entry may be cancelled in two ways: 
(1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or 
(2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.

Information for consumers

Updates on the post-market review will be published on this page as further information becomes available. 

If any recall actions are undertaken, they will 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.

Information for healthcare professionals

Specific information about each ARTG entry can be found by searching the ARTG public summary with the ARTG number that is found on the above webpage.

If you have questions or concerns regarding ongoing use or maintenance of devices that have been cancelled or suspended from the ARTG, please contact the sponsor of the device directly.

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).