As the FDA investigates China-made plastic syringes because of compatibility issues with syringe pumps, Cardinal Health said 32 million of its syringes are experiencing the same issue.
New dimensions to syringes made in China have led to leaks, breaks and other problems, the FDA said in late November. 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.
In October, the company designated more than 20 million syringes as part of the issue.
As of Jan. 5, there have been 15 reports of delayed therapy because syringe infusion pumps are not recognizing the syringes. There have also been 13 reports of inaccurate volume or rate dispensing, including some injuries, and zero reports of deaths.
Cardinal Health is not recalling the syringes; the distributor is advising customers to discontinue using affected syringes with syringe pumps but continue using Covidien products.