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).

Reason: 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.

Code information: REF MC: 230441, 230224, 230209, 230191, 230185, 230167, 230165, 230146, 230125, 230016, 225261, 225226, 225183, 225173, 225149, 225147, 225126, 225122, 225088, 225073, 225063, 225006; UDI-DI numbers 07640121880933, 17640121880930; REF MC-R: 230461, 230329, 230351, 230235, 230083, 230053, 230043, 230008, 230005, 225253, 225221; UDI-DI numbers 07640121880087, 17640121880084, 27640121880081; REF MC-I: 230372, 230339, 230336, 230229, 230206, 230132, 230117, 230051, 230044, 230012, 225299, 225298, 225280, 225255, 225218, 225216, 225190, 225185, 225184, 225175, 225120, 225091, 225089, 225064, 225058, 225033, 225023, 221064, 221056; UDI-DI numbers 07640121880506, 17640121880503. REVISED 9/21/2023: Additional lot number added for the U.S. for REF MC-I - 225119

Distribution pattern: US Nationwide distribution.