Device recall
Z-1307-2018: HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box…
FDA device recall · Class II · C.R. Bard, Inc.
Key facts
| Recall number (Z-number) | Z-1307-2018 |
|---|---|
| Recall event | 78642 |
| Product | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding… |
| Product code | EZD |
| Recalling firm | C.R. Bard, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 5, 2019 |
| 510(k) numbers | K000723, K122785 |
| FEI number | 1018233 |
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