Device recall
Z-1639-2010: Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection…
FDA device recall · Class II · Churchill Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1639-2010 |
|---|---|
| Recall event | 54174 |
| Product | Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. Intravascular administration set. |
| Product code | FPA |
| Recalling firm | Churchill Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2013 |
| 510(k) numbers | K011336 |
| FEI number | 1000120555 |
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