Recall Z-1563-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Baxter Healthcare Corporation
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-MTB; 16) 75ME-B; 17) 75MT-B; 18) 75MT-BR; 19) 75MX-B; 20) 75RE-B; 21) 75RT-B; 22) 75WE-B; 23) 75WT-B.
| Date | Apr 15, 2025 (initiated Mar 21, 2025) |
| Status | Open, Classified |
| Reason | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| Root cause | Device Design |
| Action | Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/21/2025 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate the impacted products (see Attachment A for details) at your facility that are unopened. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed Reply Form Instruction Sheet, even if you have no remaining inventory. 3. If you purchased this product from a distributor or wholesaler, |
| Quantity | 70627 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor Welch Allyn, Inc., Jun 30, 2017 |