Device recall
Z-2957-2011: HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile…
FDA device recall · Class II · Greiner Bio-One North America, Inc.
Key facts
| Recall number (Z-number) | Z-2957-2011 |
|---|---|
| Recall event | 59352 |
| Product | HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless steel needle on the underside of the holder, recommended for use with commercially available butterfly and… |
| Product code | FMI |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 3, 2011 |
| 510(k) numbers | K980768 |
| FEI number | 3001451379 |
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