sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
This recall is currently active, issued October 28, 2022. It was issued by Sentec Ag Ringstrasse 39 Therwil Switzerland.
- Recall Initiated
- August 22, 2022
- Posted
- October 28, 2022
- Recall Number
- Z-0148-2023
- Quantity
- 17208 units
- Official Source
- View on FDA website ↗
Reason for Recall
Weak skin adhesion.
Distribution
US Nationwide distribution.
Lot / Code Info
batch #220139
Root Cause
Under Investigation by firm
Action Taken
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.
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