Device recall
Z-0906-06: Gri-bag: A single use, non pyrogenic flexible empty container with an…
FDA device recall · Class II · Instituto Grifols, S.A.
Key facts
| Recall number (Z-number) | Z-0906-06 |
|---|---|
| Recall event | 34243 |
| Product | Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500… |
| Product code | KPE |
| Recalling firm | Instituto Grifols, S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2006 |
| 510(k) numbers | K033916 |
| FEI number | 3002807257 |
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