Device recall
Z-0016-2019: Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF…
FDA device recall · Class II · COVIDIEN LLC
Key facts
| Recall number (Z-number) | Z-0016-2019 |
|---|---|
| Recall event | 80924 |
| Product | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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