Recall Z-1567-2025 ยท DXQ Blood Pressure Cuff
Baxter Healthcare Corporation
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN
| 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 | 385920 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM Welch Allyn, Inc., Aug 17, 2001 |