Device recall
Z-1054-2008: CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with…
FDA device recall · Class III · Civco Medical Instruments Inc
Key facts
| Recall number (Z-number) | Z-1054-2008 |
|---|---|
| Recall event | 46743 |
| Product | CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVCO, Kalona, IA. |
| Product code | ITX |
| Recalling firm | Civco Medical Instruments Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 3, 2008 |
| 510(k) numbers | K970514 |
| FEI number | 1937223 |
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