Excelsior Saline Syringe Recall: Risk of Leaks and Loss of Sterility

A Class 1 recall has been announced for Excelsior disposable saline-filled syringes due to the risk that they could leak or lose their sterility, which could cause infection or death. 

On Tuesday, the FDA determined that an early September saline syringe recall announced to customers and distributors by Excelsior Medical Corporation should be classified as a Class 1 recall, the most serious category of medical device recall possible. According to the FDA, the defective syringes could lead to conditions that could cause serious injury or death.

The disposable syringes are filled with a saline solution and are intended to be used to flush venous access devices and intravenous (IV) lines. However, they have been found to have the potential for leaking or loss of sterility, which could cause a bloodstream infection, resulting in serious injury or death. There have been no injuries or deaths reported in connection to the defective syringes.

The recall affects Excelsior Disposable Syringes with Normal Saline. The syringes have 5 mL of solution in a 6 mL syringe with the product codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. The product codes are located on a barcode on each syringe and on the carton label. The syringes were distributed between August 8, 2008 and August 10, 2010.

The FDA recommends that consumers stop using the syringes and return them to the place of purchase. The company has instructed customers and distributors to stop using or distributing the recalled syringes. They’ve also asked all customers and distributors to confirm that they’ve received notification and made arrangements to have the syringes returned or destroyed.