FDAFDA · Food and drugs·Recall number Z-2592-2023
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).
Published September 27, 2023 · Recall initiated: July 25, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SenTec AG
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.