Reported Sep 27, 2023 · Ongoing
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each…
SenTec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SenTec AG · Ringstrasse 39 · Therwil · N/A
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Membrane Changer Single-Use, REF MC, each package contains 3 changers |
| 2 | Membrane Changer Reloadable, REF MC-R, each package contains 3 changers |
| 3 | and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS). |
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 230441, 230224, 230209, 230191, 230185, 230167, 230165, 230146, 230125, 230016, 225261, 225226, 225183, 225173, 225149, 225147, 225126, 225122, 225088, 225073, 225063, 225006 2 0764012188093317640121880930UDI-DI numbers 07640121880933, 17640121880930 3 REF MC-R: 230461, 230329, 230351, 230235, 230083, 230053, 230043, 230008, 230005, 225253, 225221 4 076401218800871764012188008427640121880081UDI-DI numbers 07640121880087, 17640121880084, 27640121880081 5 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 6 0764012188050617640121880503UDI-DI numbers 07640121880506, 17640121880503. REVISED 9/21/2023: Additional lot number added for the U.S. for REF MC-I - 225119 - Amount recalled
- REVISED 9/21/2023-15,065 packages
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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