Device recall
Z-0897-2015: Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0897-2015 |
|---|---|
| Recall event | 69842 |
| Product | Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe. |
| Product code | FMI |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K041399 |
| FEI number | 1217052 |
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