Recall Z-0935-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
| Date | Jan 21, 2011 (initiated Dec 1, 2010) |
| 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 the two customers on December 1, 2010, informing them that that a post repair test was not performed correctly on their Colleague pumps (serial numbers 12070599CC and 17086323CP) 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 then send a shipping container for retrieval, reinspection and return of the devi |
| Quantity | 14 pumps |
| Distribution | Nationwide Distribution -- Arizona, Indiana, *** California, Iowa, New Jersey, Ohio, Virginia and West Virginia***. |
| 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 |