SenTec AG: 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).

Recall number

Z-2592-2023

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).

Status

Open, Classified

Initiated

2023-07-25

Posted

2023-09-15

Terminated

not on file

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.

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

REVISED 9/21/2023-15,065 packages

Distribution

US Nationwide distribution.

Lot, serial or model codes

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

510(k) numbers

["K041548","K101690","K151329"]

PMA numbers

not on file

Product code

LKD

Firm FEI

3004149774

Firm city

Therwil

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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