Recall Z-1059-05 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, 2M8151R, 2M8161, 2M8161R
| Date | Aug 10, 2005 (initiated Jul 20, 2005) |
| Status | Terminated |
| Reason | A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes. |
| Root cause | Device Design |
| Action | Baxter sent the 7/20/05 Urgent Product Recall letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via overnight delivery to alert them of a patient death which may have been associated with an electronic failure resulting from a design issue with the pump, and listed failure codes 402, 403, 532, 533, 534, 535, 702, 703, 704, 720, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 that may be related to the electronic failure. The users were advised to have a contingency plan to mitigate any disruptio |
| Quantity | 152,260 pumps |
| Distribution | Nationwide including Puerto Rico, and internationally to Australia, the Bahamas, Bahrain, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, the United Arab Emirates and teh |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041191 | COLLEAGUE VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp, Jun 25, 2004 |