Class 2 Device Recall sentec

• Date Initiated by Firm: August 22, 2022
• Date Posted: October 28, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0148-2023
• Recall Event ID: 90938
• 510(K)Number: K151329
• Product Classification: Monitor, carbon-dioxide, cutaneous - Product Code LKD
• Product: sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
• Code Information: batch #220139
• Recalling Firm/ Manufacturer: SenTec AG; Ringstrasse 39; Therwil Switzerland
• For Additional Information Contact: Mr Bob Cormier; 401-374-3781
• Manufacturer Reason for Recall: Weak skin adhesion.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued a letter to its consignees on 08/22/2022 regarding below standard adhesion properties of the MARe-SF (Multisite Attachment Rings - for Sensitive, Fragile skin) product containing replacement product in the form of the premium product - the Patient Application Kit (PAK-SF) and the recommendation to discard the affected product.
• Quantity in Commerce: 17208 units
• 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