Recall Z-1023-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R
| Date | Jul 21, 2005 (initiated Mar 15, 2005) |
| Status | Terminated |
| Reason | The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11. |
| Root cause | Device Design |
| Action | Baxter sent the 3/15/05 Urgent Device Correction letter to all Colleague Infusion Pump customers to alert them of actions they can take in the short-term to address specific user actions and several error codes in the event of an occurrence, which could lead to serious adverse health consequences if a patient is receiving life-sustaining medication at the time of the pump failure. Users were urged to verify that the pump is infusing after pressing the Start key. If the hospital uses the external monitoring capabilities of the pump for a nurse call or remote pump monitoring, they were request |
| Quantity | 53,686 pumps |
| Distribution | Nationwide including Puerto Rico, and internationally to Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041191 | COLLEAGUE VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp, Jun 25, 2004 |