Device recall
Z-2221-2016: Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per…
FDA device recall · Class II · WalkMed Infusion, LLC
Key facts
| Recall number (Z-number) | Z-2221-2016 |
|---|---|
| Recall event | 74437 |
| Product | Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. |
| Product code | FPA |
| Recalling firm | WalkMed Infusion, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 1, 2016 |
| 510(k) numbers | K073444 |
| FEI number | 3000204189 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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