Merit Medical recalls plastic syringes manufactured by Jiangsu Shenli

Merit Medical Systems has recalled products containing plastic syringes from Chinese manufacturer Jiangsu Shenli Medical Production, per the FDA. The recall affects kits with syringes not meeting authorized specifications, as highlighted by an FDA import alert and warning earlier this year.

After discovering the inclusion of Jiangsu Shenli syringes from its supplier, Merit promptly advised customers to discontinue use. This action mirrors FDA scrutiny over 29 piston syringe configurations marketed without proper clearance.

Similarly, Medline Industries received a warning letter and conducted recalls related to Jiangsu Shenli syringes recently. Merit issued an urgent recall notice, allowing continued use of other kit components but urging immediate cessation of the syringes' use.

During the transition away from Jiangsu Shenli syringes, Merit plans to label recalled syringes in shipped kits to manage supply continuity. The FDA's Class 2 recall notice impacts 110,000 devices under Merit's Medigrative brand, prompting Jiangsu Shenli to instruct U.S. customers on proper disposal methods.

The recalls underscore ongoing efforts to address quality concerns in disposable medical devices, coinciding with similar actions by Medline.