The FDA recently warned healthcare professionals of a recall of MPS Delivery Sets by Quest Medical, Inc. The Sets are used to deliver solutions to the heart during cardiopulmonary bypass surgeries. Quest Medical has recalled certain lots of these defective medical devices that were distributed between June 2015 and September 2015. The reason for the nationwide recall is a “seal failure along the blood source channel of main pump cassette”, which could lead to patient blood loss. The recalling firm has received 20 complaints of seal failure, 16 of which “have resulted in… patient blood loss during surgery.”
Quest Medical has notified the FDA and its customers of the voluntary recall of the affected MPS delivery sets.
One of FDA’s primary responsibilities is protecting the public health by ensuring that pharmaceuticals and medical devices in use are safe. As such, the FDA oversees the recall process, or market withdrawal, of dangerous pharmaceuticals and defective medical devices.