Quest Medical, Inc.

For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Delivery Sets may have tubing that could become detached that could result in patient infection.

The products have been found to intermittently exhibit a seal failure during use.

Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels

User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles.

Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention.