Device recall
Z-1613-2012: Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO…
FDA device recall · Class II · Galil Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1613-2012 |
|---|---|
| Recall event | 61657 |
| Product | Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product Usage: Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of… |
| Product code | GEH |
| Recalling firm | Galil Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2012 |
| 510(k) numbers | K060144 |
| FEI number | 3004462490 |
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