Dive Brief:
- Merit Medical Systems has recalled products that contain plastic syringes made by a Chinese manufacturer, the Food and Drug Administration said Friday.
- The recall affects kits that include unauthorized syringes manufactured by Jiangsu Shenli Medical Production. The FDA issued an import alert and warning letter against Jiangsu Shenli earlier this year after finding it was providing syringes that were different from its authorized device.
- Merit wrote to customers last week after learning that it received Jiangsu Shenli syringes from a supplier. The company has asked customers to stop using the syringes.
Dive Insight:
The FDA’s investigation into the potential for plastic syringes made in China to leak, break and otherwise suffer quality problems led it to Jiangsu Shenli. Officials accused the company of marketing 29 sizes and configurations of piston syringes without clearance or approval.
Medline Industries received a warning letter linked to its distribution of the Jiangsu Shenli syringes and recalled its devices in May and June.
Merit sent an urgent medical device recall notice about its distribution of Jiangsu Shenli syringes last week. The company said it included the syringes in multiple products. Customers can continue to use the other components included in the kits but should immediately stop using and distributing the syringes.
As Merit is moving away from Jiangsu Shenli syringes, it may ship kits that contain the devices to avoid product shortages during a transition period. The company will apply a recall label to affected syringes.
The action affects 110,000 devices, according to the FDA’s Class 2 recall notice. The notice applies to disposable luer lock syringes that Merit sells under the Medigrative brand and lists Jiangsu Shenli as the recalling firm.
Jiangsu Shenli has asked customers to dispose of recalled syringes in the U.S. using their established procedures or by working with a local third party. Customers should “report the destruction method and cost with Shenli before final implementation,” according to the notice.
Merit’s recall comes days after the FDA announced additional recalls by Medline. The company began recalls of luer lock disposable syringes shortly after an initial action that affected 2.3 million devices.
