Recall Z-0745-2012 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8153. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable
| Date | Jan 13, 2012 (initiated Jul 14, 2010) |
| Status | Terminated |
| Reason | Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
| Root cause | Employee error |
| Action | Baxter sent service technicians to the consignees location on July 14, 2010 and October 6, 2010 and conducted the ground impedance and leakage current test on the affected pumps. The pumps were found with specifications. |
| Quantity | 1 unit |
| Distribution | Nationwide 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 |