Device recall
Z-0596-2014: Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in…
FDA device recall · Class II · Asante Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-0596-2014 |
|---|---|
| Recall event | 66895 |
| Product | Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark |
| Product code | FPA |
| Recalling firm | Asante Solutions, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2014 |
| 510(k) numbers | K120872 |
| FEI number | 3009351200 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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