Device recall
Z-0318-2018: HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles…
FDA device recall · Class II · Repro-Med Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0318-2018 |
|---|---|
| Recall event | 76569 |
| Product | HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609… |
| Product code | FPA |
| Recalling firm | Repro-Med Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 26, 2018 |
| 510(k) numbers | K122404 |
| FEI number | 1318360 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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