Maquet Cardiovascular, LLC recalls Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01

Recall date

April 18, 2019

Source

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

Recall number

Z-1637-2019

FDA classification

Class II

Brand / firm

Maquet Cardiovascular, LLC

Sold / distributed

Nationwide

Why it was recalled

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

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

What was recalled

Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01