Recall Z-2222-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161 and 2M9161. 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 soluti
| Date | May 19, 2011 (initiated Apr 14, 2011) |
| Status | Terminated |
| Reason | The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user. |
| Root cause | Employee error |
| Action | The firm, Baxter Healthcare Corporation, telephoned the customers on April 14, 2011, informing them that that the Hi-Pot test,and sent a follow up "URGENT DEVICE CORRECTION" letter dated April 27, 2011, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the pumps and take them out of service as soon as possible (Baxter will then send a shipping container for retrieval, re-inspection and return of the device back to the customer at no cost.); and return their colleague pumps for full functional testing including the HiP |
| Quantity | 117 pumps |
| Distribution | Worldwide distribution: USA (nationwide) including states of :Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and We |
| 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 |