Recall Z-1037-2009 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore. Product Codes: 2M8151, 2M8161, 2M9161, DNM8151, DNM9161, BRM8151, BRM8151T, BRM8151RT, PNM8151, PNM8151T, PNM8151RT, CNM8151, FKM8151, GNM8151, HNM8151, TRM8151 and WNM8151. Electronic infusion pumps are indicated for continuous
| Date | Mar 2, 2009 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps. |
| Root cause | Device Design |
| Action | Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injur |
| Quantity | 221,097 pumps |
| Distribution | Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jam |
| 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 |