Device recall
Z-0480-2009: INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025…
FDA device recall · Class II · Enterix, Inc.
Key facts
| Recall number (Z-number) | Z-0480-2009 |
|---|---|
| Recall event | 49560 |
| Product | INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R)… |
| Product code | KHE |
| Recalling firm | Enterix, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 26, 2009 |
| 510(k) numbers | K060930 |
| FEI number | 3003224146 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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