Device recall
Z-0716-2021: PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free…
FDA device recall · Class II · Prytime Medical Devices, Inc.
Key facts
| Recall number (Z-number) | Z-0716-2021 |
|---|---|
| Recall event | 86797 |
| Product | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring… |
| Product code | MJN |
| Recalling firm | Prytime Medical Devices, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2023 |
| 510(k) numbers | K193440 |
| FEI number | 3026788751 |
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