Recall Z-3008-2011 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161
| Date | Aug 11, 2011 (initiated Jul 22, 2011) |
| Status | Terminated |
| Reason | A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy. |
| Root cause | Other |
| Action | The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 84 |
| Quantity | 1 pump |
| Distribution | Nationwide distribution: Missouri only. |
| 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 |