Device recall
Z-0017-2019: Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103…
FDA device recall · Class II · COVIDIEN LLC
Key facts
| Recall number (Z-number) | Z-0017-2019 |
|---|---|
| Recall event | 80924 |
| Product | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Product code | NAD |
| Recalling firm | COVIDIEN LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 3, 2020 |
| 510(k) numbers | K990530 |
| FEI number | 1282497 |
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