Home / Recalls / Medical Devices
SenTec AG recalls Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each packa
Recalled September 27, 2023 · FDA recall Z-2592-2023 · SenTec AG
Hazard
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. · FDA Class II
Units
REVISED 9/21/2023-15,065 packages
Sold at
US Nationwide distribution.
Description
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.
Product
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).
Manufacturer(s)
SenTec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →