Device recall
Z-0357-2017: AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80…
FDA device recall · Class II · Unomedical As
Key facts
| Recall number (Z-number) | Z-0357-2017 |
|---|---|
| Recall event | 74242 |
| Product | AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion… |
| 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