Recall Z-2796-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
| Date | Jul 13, 2011 (initiated May 4, 2011) |
| Status | Terminated |
| Reason | The Air In Line (AIL) test was not properly performed by the service technician at the Service Center. |
| Root cause | Employee error |
| Action | Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed a |
| Quantity | 12 pumps |
| Distribution | Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and 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 |