Recall Z-1224-2007 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161
| Date | Sep 19, 2007 (initiated Aug 15, 2007) |
| Status | Terminated |
| Reason | Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade. |
| Root cause | Other |
| Action | The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt a |
| Quantity | 42 pumps |
| Distribution | Florida and California |
| 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 |