Device recall
Z-1667-2021: REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning…
FDA device recall · Class II · Bard Access Systems Inc.
Key facts
| Recall number (Z-number) | Z-1667-2021 |
|---|---|
| Recall event | 87594 |
| Product | REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed. |
| Product code | LJS |
| Recalling firm | Bard Access Systems Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2023 |
| 510(k) numbers | K063240, K201452 |
| FEI number | 3006260740 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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