Device recall
Z-1368-2018: Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage…
FDA device recall · Class II · Teleflex Medical Europe Ltd
Key facts
| Recall number (Z-number) | Z-1368-2018 |
|---|---|
| Recall event | 79579 |
| Product | Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled. |
| Product code | FAP |
| Recalling firm | Teleflex Medical Europe Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K962472 |
| FEI number | 3007134520 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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