Cardinal Health is notifying customers of incompatibility between syringe pumps and more than 20 million of its Luer-Lock Tip Soft Pack syringes.
In mid-October, Cardinal Health sent a voluntary medical device product correction letter concerning more than 3.9 million of its syringes because of the issue. As of Oct. 26, more than 16.6 million syringes have been added to the list, according to an FDA database.
The latest notice is classified as a Class I recall, the most serious type; using the product could lead to serious adverse events or death. The first 3.9 million syringes were classified as Class II.