—#105786

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected lot / code info: Product Code: 2M8161, Serial Number 12050019CC

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Puerto Rico

Timeline

Recall initiated: 2009-05-08
Posted by FDA: 2012-01-11
Terminated: 2012-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.