Z-2592-2023Class II

Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R...

Name: Z-2592-2023 Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R...
Creator: SenTec AG
Published: 2023-07-25
License: https://open.fda.gov/license/

Sentec AG / initiated 2023-07-25 / Open, Classified / root cause: manufacturing process

FDA source

SenTec AG began a recall of Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane... on 2023-07-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2592-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-25
Posted: 2023-09-15
Recalling firm: Sentec AG
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).
Product code: LKD Monitor, Carbon-Dioxide, Cutaneous
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified Sentec distributors in a letter flagged Guidance for Sentec Distributors dated 7/25/2023 via email on 7/25/2023 (letter #RF-013993-a). The letter listed the devices impacted, the defect, how it manifests itself, and the risks (impact on measurement readings, impact on the sensor membrane, and harm to patient skin). Actions for the distributor and subdistributor level were provided. Subdistributors were to be informed who received the affected products by forwarding them this guidance document and related attachments using a read receipt on the email. The distributor is to follow-up with each subdistributor to ensure they understand the information provided and that each subdistributor will implement all actions as required and on time. The distributor is to confirm that these tasks have been executed by 7/31/2023. Potential return of product by the distributors will occur. All end customers within the distributor's territory are to be informed using the Customer Information Letter dated 7/25/2023 (letter #RF-013992-a) which was attached to the Guidance for Sentec Distributors. These letters were to be sent via email using a read receipt. The Customer Information Letter also contained information on the devices impacted, what the defect is, how it manifests itself, and the risks (impact on measurement readings, impact on the sensor membrane, and harm to patient skin). The end user is to identify any lots they may still have at their institution and if any of the affected products are in stock, the recalling firm recommends they follow the visual inspection steps shown in the enclosed Appendix I. If a defective membrane is detected, they are to replace it immediately. The customer is referred to Appendix I and II or the Instruction Manuals listed in the letter for the IFU procedure and picture of what a defective membrane may look like. Enclosed Appendix III contains a table listing the affected lot numbers for the Membran
Quantity in commerce: REVISED 9/21/2023-15,065 packages
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2592-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2592-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-15

Product code LKD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)