Device recall
Z-3174-2011: Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy…
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-3174-2011 |
|---|---|
| Recall event | 59564 |
| Product | Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection… |
| Product code | EXB |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2012 |
| FEI number | 2125050 |
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