Device recall
Z-1744-2014: BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled…
FDA device recall · Class II · BioDerm, Inc.
Key facts
| Recall number (Z-number) | Z-1744-2014 |
|---|---|
| Recall event | 68313 |
| Product | BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device. |
| Product code | NEC |
| Recalling firm | BioDerm, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 20, 2014 |
| FEI number | 3001949129 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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