Device recall
Z-1332-2011: FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First…
FDA device recall · Class II · Churchill Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1332-2011 |
|---|---|
| Recall event | 57295 |
| Product | FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 Intended use: Intravascular Administration Set |
| Product code | FPA |
| Recalling firm | Churchill Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 1, 2012 |
| 510(k) numbers | K011336 |
| FEI number | 1000120555 |
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