Device recall
Z-1241-2013: Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-1241-2013 |
|---|---|
| Recall event | 64705 |
| Product | Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being… |
| Product code | MQF |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2021 |
| 510(k) numbers | K033084, K990349, K990350 |
| FEI number | 1217052 |
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