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

FDA device recall Z-2592-2023 · posted 2023-09-15 · Open, Classified

Recall details

Recalling firm

SenTec AG

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.

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

LKD

Quantity affected

REVISED 9/21/2023-15,065 packages

Distribution

US Nationwide distribution.

Date initiated

2023-07-25

Date posted

2023-09-15

Location

Therwil, Switzerland

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