Device recall
Z-1378-2011: InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare…
FDA device recall · Class III · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-1378-2011 |
|---|---|
| Recall event | 57666 |
| Product | InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; product codes 2L3100, 2L3100R, 2L3100U, 6461500 and 6461500R. These product codes includes refurbished units and InfusO.R. pumps previously sold under the Bard label. Intended for the… |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 27, 2012 |
| 510(k) numbers | K883577 |
| 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