Maquet Cardiovascular Us Sales, Llc recalls HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP…

Recall date

March 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1690-2015

FDA classification

Class II

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, South…

Why it was recalled

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.