Recall Z-2592-2023 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
SenTec AG
Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).
| Date | Sep 15, 2023 (initiated Jul 25, 2023) |
| Status | Open, Classified |
| Reason | During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance. |
| Root cause | Process control |
| Action | The recalling firm notified Sentec distributors in a letter flagged Guidance for Sentec Distributors dated 7/25/2023 via email on 7/25/2023 (letter #RF-013993-a). The letter listed the devices impacted, the defect, how it manifests itself, and the risks (impact on measurement readings, impact on the sensor membrane, and harm to patient skin). Actions for the distributor and subdistributor level were provided. Subdistributors were to be informed who received the affected products by forwarding them this guidance document and related attachments using a read receipt on the email. The distrib |
| Quantity | REVISED 9/21/2023-15,065 packages |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041548 | SENTEC DIGITAL MONITOR MODEL #SDM Sentec, Inc., Aug 9, 2004 |
| K101690 | SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE Sentec AG, Dec 3, 2010 |
| K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet Sentec AG, Dec 17, 2015 |