Dive Brief:

• Cardinal Health has recalled procedure kits that contain plastic syringes made by China’s Jiangsu Shenli Medical Production, the Food and Drug Administration said Thursday.
• The recall affects Cardinal Presource products. Cardinal sourced some devices in the packs from Merit Medical Systems, which recently recalled its own kits after learning they contained Jiangsu Shenli syringes. 
• Cardinal listed more than 500 product catalog numbers in its recall notice. The company has told customers to remove and discard Jiangsu Shenli syringes included in the kits. Cardinal issued the recall on May 28 and published a press release on June 18.

Dive Insight:

Cardinal provides Presource surgical packs to give physicians the devices they need to perform specific procedures such as angiographies and neurointerventional surgeries. The company includes finished kits from Merit as components in some of its Presource packs. 

Merit’s supplier sent it plastic syringes made by Jiangsu Shenli, a Chinese device manufacturer that is the subject of a FDA import alert and warning letter. The FDA found Jiangsu Shenli was providing syringes that differed from its authorized device. Merit recalled its kits after learning they contained the Jiangsu Shenli syringes targeted by the FDA.

Before the recall, Merit supplied some of the affected kits to Cardinal, which included them in its own Presource packs. Cardinal has recalled packs that contain the affected Merit kits. Customers should quarantine and label affected packs, Cardinal said, so physicians know to remove and discard syringes from the Merit kits. The other devices in the Merit kits are suitable for use.

The recall follows an FDA warning letter focused on Cardinal’s distribution of Jiangsu Shenli syringes. The FDA found Cardinal sold convenience kits that contained 3 mL, 10 mL and 20 mL piston syringes made by Jiangsu Shenli. The Chinese manufacturer only has 510(k) clearance for a 5 mL luer-lock piston syringe.

Jiangsu Shenli received a warning letter for supplying unauthorized devices in March. Two U.S. distributors of China-made plastic syringes, Medline Industries and Sol-Millennium Medical, received warning letters at the same time as Jiangsu Shenli.