Device recall
Z-0355-2017: Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm…
FDA device recall · Class II · Unomedical As
Key facts
| Recall number (Z-number) | Z-0355-2017 |
|---|---|
| Recall event | 74242 |
| Product | Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5… |
| Product code | FPA |
| Recalling firm | Unomedical As |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2016 |
| 510(k) numbers | K120872 |
| FEI number | 1000477110 |
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