Class 2 Device Recall Sentec Digital Monitoring System (model SDMS)

• Date Initiated by Firm: July 25, 2023
• Date Posted: September 15, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2592-2023
• Recall Event ID: 92833
• 510(K)Number: K041548 K101690 K151329
• Product Classification: Monitor, carbon-dioxide, cutaneous - Product Code LKD
• 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).
• 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
• Recalling Firm/ Manufacturer: SenTec AG; Ringstrasse 39; Therwil Switzerland
• For Additional Information Contact: Mr. Bob Cormier; 877-425-8746
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LKD and Original Applicant = SENTEC AG; 510(K)s with Product Code = LKD and Original Applicant = SENTEC INC.