Device recall
Z-1826-2018: (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS)…
FDA device recall · Class II · COVIDIEN MEDTRONIC
Key facts
| Recall number (Z-number) | Z-1826-2018 |
|---|---|
| Recall event | 79974 |
| Product | (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0) (3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0 BBR STVEIT GASTRIC B) Product Usage: The Endo GIA universal and Endo GIA… |
| Product code | GDW |
| Recalling firm | COVIDIEN MEDTRONIC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2020 |
| 510(k) numbers | K111825 |
| FEI number | 1219930 |
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