Device recall
Z-1673-2021: ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount…
FDA device recall · Class II · Welch Allyn Inc
Key facts
| Recall number (Z-number) | Z-1673-2021 |
|---|---|
| Recall event | 87749 |
| Product | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP). |
| Product code | DXN |
| Recalling firm | Welch Allyn Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2024 |
| 510(k) numbers | K101680 |
| FEI number | 1316463 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database