Dive Brief:
- Medline Industries and Jiangsu Shenli Medical Production have initiated recalls for plastic syringes, adding to the list of recent safety problems concerning syringes made in China and distributed in the U.S.
- The Food and Drug Administration announced Medline’s recall on Thursday and Jiangsu Shenli’s on Tuesday. Medline told customers in an April safety notice to stop using plastic syringes in convenience kits and “destroy the affected devices,” following the FDA’s March warning about safety and quality concerns with the products.
- Jiangsu Shenli, a Chinese manufacturer, recalled more than 100 million plastic syringes, affecting 82 products, according to a May 20 FDA enforcement report entry. An FDA spokesperson confirmed in an emailed statement the recall has not yet been classified, adding that the agency is currently reviewing the action and will update database entries as statuses change.
Dive Insight:
Over the past several months, the FDA has posted numerous warnings and notices about plastic syringes made in China and distributed in the U.S. The actions include sending warning letters to manufacturers, implementing import alerts to prevent products from entering the country and warning healthcare providers and the public about safety concerns with the syringes.
Amid the FDA’s actions, President Joe Biden said last week that the U.S. would increase tariffs on certain medical products and supplies from China.
The agency has advised providers to immediately stop using the syringes, some of which are not authorized to be sold or distributed in the U.S., because of quality and performance issues that can impact patient safety.
Medline echoed those concerns in its letter to customers, writing that leaks, breakage and other quality issues have been identified in convenience kits containing syringes.
“Syringes contained within the impacted kits should not be used and should be discarded, except for circumstances where no alternative syringes are readily available,” the company wrote. “If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA.”
In Medline’s March warning letter, the FDA noted that the company distributed syringes produced by Jiangsu Shenli for use in the U.S.
In April, Jiangsu Shenli also launched a recall for plastic syringes. The FDA’s enforcement report entry for the recall states, “Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).”
Jiangsu Shenli has been at the heart of the FDA’s probe into plastic syringes made in China. The manufacturer has received an FDA warning letter and two import alerts regarding its products.
The FDA did not state how many injuries or deaths have been connected to Jiangsu Shenli’s recall, and Medline did not state any figures in its letter.
“The FDA will continue our efforts to evaluate problems with syringes made in China, including facility inspections, examining products at the border and detaining them as appropriate, laboratory testing of syringes, and working with manufacturers, when applicable, to ensure adequate corrective actions are taken,” wrote the FDA spokesperson.
