Recall Z-1509-2024 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Baxter Healthcare Corporation
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,EU, Product Code 34BFST-2; b) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,UK, Product Code 34BFST-4; c) PROBP 3400, SUREBP, BLUETOOTH, MOBILE,AU, Product Code 34BFST-6; d) PROBP 3400, BLUETOOTH, MOBILE, EU, Product Code 34BXST-2; e) PROBP 3400, BLUETOOT
| Date | Apr 10, 2024 (initiated Mar 26, 2024) |
| Status | Open, Classified |
| Reason | Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards. |
| Root cause | Nonconforming Material/Component |
| Action | Baxter issued an Urgent Medical Device Correction notice to its consignees on 03/26/2024 via USPS, first class mail. The notice explained the issue, hazard, and provided the following: Actions to be taken by customers: 1. Healthcare providers may continue to use the non-compliant power cords, but if any fraying or damage is observed, users should NOT make physical contact with the cord and discard the power cord immediately. 2. Healthcare providers should regularly inspect the power cords for fraying or other damage. 3. Once Baxter has replacement power cords, a follow-up notification will |
| Quantity | 11154 units |
| Distribution | Global, US: NY, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES Welch Allyn, Inc., Jul 9, 2010 |