sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carb
Summary
The FDA issued a Class II for sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ski by SenTec AG. Reason: Weak skin adhesion..
Details
Source
Device Recall
External ID
Z-0148-2023
Action Date
2022-11-09
Status
Terminated
Category
device
Product Description
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Lot/Code Info: batch #220139
Quantity Affected: 17208 units
Reason for Recall
Weak skin adhesion.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-22
Company
Therwil, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SenTec AG has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SenTec AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SenTec AG have FDA actions?
SenTec AG has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0148-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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