Recall Z-0598-2012 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
| Date | Jan 11, 2012 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | There was no documentation to show the required tests were performed following the replacement of the battery and battery harness. |
| Root cause | Process control |
| Action | Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification. |
| Quantity | one pump |
| Distribution | Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063696 | COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 Baxterhealthcare, Inc., Feb 27, 2007 |