On Wednesday, January 25th, the FDA issued Import Alert 89-17, which banned the import of Nipro’s piston syringes (with luer lock tip or catheter tip) into the US from the company’s Thailand location.
As noted in the Agency’s alert, section 501(c) of the Federal Food, Drug, & Cosmetic (FD&C) Act states that “a device is adulterated if its quality falls below that which it purports or is represented to possess.” Furthermore, FDA states that it “has collected and analyzed samples of various medical devices which have not met the quality level that they purported or were represented to possess, in accordance with acceptance criteria in a standard or in a manufacturer’s Quality System (QS) Regulation acceptance procedure. Devices which do not meet their own established medical device specifications or the quality level they were represented to meet could result in a potential health risk to the end user.”
According to a recent article from RAPS, Nipro has not responded to their request for a comment.
For additional information, view the FDA’s full import alert.