SenTec AG recalls Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each pack…

Recall date

July 25, 2023

Source

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

Recall number

Z-2592-2023

FDA classification

Class II

Brand / firm

SenTec AG

Sold / distributed

US Nationwide distribution.

Why it was recalled

During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

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

What was recalled

Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).