Sol-Millennium Syringe Recall Issued Amid FDA Crackdown on Plastic Chinese-Made Syringes
Recalled Chinese syringes were not approved by the FDA, and may be prone to leaking and breaking, causing life-threatening injuries and complications
Recalled Chinese syringes were not approved by the FDA, and may be prone to leaking and breaking, causing life-threatening injuries and complications
FDA never approved recent changes in manufacturers and new dimensions for the syringe sizes, which led to a massive Monoject syringe recall earlier this year
If no other syringes are available, doctors are urged to carefully monitor patients when the Chinese-made syringes are used, which may leak, break or cause other life-threatening complications
Warning letters over plastic syringe problems were sent to both Chinese manufacturers and U.S. distributors, due to quality control and safety issues.
The FDA has declared a February product correction as a Class I Monoject syringe recall, following numerous reports of problems with the new syringes' dimensions.
The FDA first warned of problems with Cardinal Health Monoject syringes failing to fit drug pumps in November 2023.
About a dozen incompatibility problems with Alaris infusion pumps and Cardinal Health Monoject syringes have been reported.
Problems with the plastic syringes from China may result in the delivery of incorrect medication dosages, the agency warns.
Warning comes after Cardinal Health recalled more than 32 million syringes in September, because they may not fit correctly into certain pain management drug pumps.
The FDA warns that the recalled syringes could cause infections, blood loss, increased blood clot risks, embolism and death.