Recall Z-0931-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
| Date | Jan 21, 2011 (initiated Dec 1, 2010) |
| Status | Terminated |
| Reason | While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection. |
| Root cause | Employee error |
| Action | Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (8 |
| Quantity | 1 pump |
| Distribution | Texas |
| 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 |