It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements, but it’s not every day that the head of the Center for Devices and Radiological Health (CDRH) issues a statement warning consumers not to use such products. On 19 March, CDRH Director Jeff Shuren said the agency had sent Jiangsu Shenli Medical, Sol-Millennium Medical, and Medline Industries warning letters for failing to meet quality system requirements and told the public to avoid using such syringes unless there are no other alternatives.
“The FDA has continued its extensive efforts to evaluate problems with plastic syringes made in China, including facility inspections for Medline Industries, LP and Sol-Millennium Medical, Inc., examining and detaining products at the border, laboratory testing of syringes, and working with applicable manufacturers to ensure adequate corrective actions are taken,” Shuren said in a statement. “Our ongoing evaluation has confirmed that issues with the quality of plastic syringes made in China and their distribution in the U.S. are more widespread than originally known.”…
