The FDA has approved a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).

Cardinal has 510 (k) clearance for a 5 mL luer-lock piston syringe made by Jiangsu Shenli, but it also sold convenience kits with 3 mL, 10 mL and 20 mL piston syringes that had not been cleared by ...

The FDA found that Cardinal Health 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 ...

In an April 24 letter to Steve Mason, president and CEO of Dublin, Ohio-based Cardinal Health, FDA officials said that the firm's "failure to ensure the syringes you are including in convenience ...

Cardinal Health has recalled about 267 million prefilled syringes after finding the plunger may pull back and reintroduce air into the syringe, which could cause serious adverse outcomes.

The FDA has alerted healthcare providers not to use Cardinal Health (CAH) Monoject syringes with syringe pumps and patient-controlled analgesia pumps over compatibility concerns.

To date, the recall includes 1-, 6-, 12-, 20-, 35- and 60-mL sizes of Cardinal-branded, luer-lock tip Monoject syringes. The company also sells 10- and 140-mL versions of its standard syringes ...

In mid-2023, Cardinal Health began distributing Monoject Luer-Lock syringes with different dimensions than “previously branded ‘Covidien Monoject syringes,'” the agency said Jan. 5.