Baxter Healthcare Corp. Rt. Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
Brand
Baxter Healthcare Corp. Rt.
Lot Codes / Batch Numbers
Product Code: 2M8161, Serial Number 12050019CC
Products Sold
Product Code: 2M8161, Serial Number 12050019CC
Baxter Healthcare Corp. Rt. is recalling Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. due to There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
Recommended Action
Per FDA guidance
Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026