Recall Z-0148-2023 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
| Date | Oct 28, 2022 (initiated Aug 22, 2022) |
| Status | Terminated |
| Reason | Weak skin adhesion. |
| Root 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 | 17208 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, Dec 17, 2015 |