Device recall
Z-1217-2019: Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO…
FDA device recall · Class II · Guangzhou Improve Medical Instruments Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1217-2019 |
|---|---|
| Recall event | 80547 |
| Product | Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4)… |
| Product code | FMI |
| Recalling firm | Guangzhou Improve Medical Instruments Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K123987 |
| FEI number | 3008449424 |
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