Recall Z-1543-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R
| Date | Sep 23, 2005 (initiated Feb 25, 2005) |
| Status | Terminated |
| Reason | Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs. |
| Root cause | Labeling design |
| Action | Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries |
| Quantity | 152,260 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 |