FDA Device

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.

Hazard

There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

What You Should Do

Remedy

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.

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Products

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
Brand
Baxter Healthcare Corp. Rt.
UPC
Product Code: 2M8161, Serial Number 12050019CC

Units Affected

one pump

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