Device recall
Z-0013-2019: Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF…
FDA device recall · Class II · COVIDIEN LLC
Key facts
| Recall number (Z-number) | Z-0013-2019 |
|---|---|
| Recall event | 80924 |
| Product | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| 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