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U.S. Department of Health and Human Services

Class 2 Device Recall sentec

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  Class 2 Device Recall sentec see related information
Date Initiated by Firm August 22, 2022
Date Posted October 28, 2022
Recall Status1 Open3, 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 2		 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 and Original Applicant = SENTEC AG
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