Device recall
Z-2005-2025: REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30…
FDA device recall · Class II · Becton Dickinson Infusion Therapy Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2005-2025 |
|---|---|
| Recall event | 96865 |
| Product | REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly |
| Product code | FOZ |
| Recalling firm | Becton Dickinson Infusion Therapy Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201075 |
| FEI number | 1710034 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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