Device recall
Z-2294-2010: Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-2294-2010 |
|---|---|
| Recall event | 56281 |
| Product | Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable… |
| Product code | DYB |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K093232 |
| FEI number | 2183787 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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