Device recall
Z-0028-2013: Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile…
FDA device recall · Class II · Remington Medical Inc.
Key facts
| Recall number (Z-number) | Z-0028-2013 |
|---|---|
| Recall event | 63070 |
| Product | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The… |
| Product code | KNW |
| Recalling firm | Remington Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 15, 2013 |
| 510(k) numbers | K982401 |
| FEI number | 1000132370 |
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