Device recall
Z-1866-2011: HydroHydrofilm is for use as a post-operative and primary dressing to protect…
FDA device recall · Class III · Hartmann USA, Inc
Key facts
| Recall number (Z-number) | Z-1866-2011 |
|---|---|
| Recall event | 58136 |
| Product | HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany |
| Product code | MGP |
| Recalling firm | Hartmann USA, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 12, 2011 |
| FEI number | 1218946 |
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