Device recall
Z-0935-2011: Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0935-2011 |
|---|---|
| Recall event | 57516 |
| Product | Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2012 |
| 510(k) numbers | K063696 |
| FEI number | 1416980 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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