A Class I recall has been issued on Medtronic’s SynchroMed II drug infusion pumps.
The recall was deemed necessary after the manufacturer admitted that the motor can stall on the devices, especially when they’re used to dispense unapproved drug treatments. The recall includes SynchroMed II infusion pumps manufactured from May 1998 until November 2012. They were distributed from April 1999 until November 2012.
A Class I recall from the Food and Drug Administration means that use of a medical device or drug will likely result in serious injuries or death.
The recall includes the following SynchroMed drug infusion pumps: SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.) and the SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. [Read more...]