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Terminated

sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

FDA Recall Z-0148-2023 · Posted 2022-10-28

Recalling FirmSenTec AG
Recall StatusTerminated
Product CodeLKD
Date Initiated2022-08-22
Date Terminated2026-05-26
Product Quantity17208 units

Reason for Recall

Weak skin adhesion.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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