Class 2 Device Recall Colleague CX Infusion Pump

• Date Initiated by Firm: May 08, 2009
• Date Posted: January 11, 2012
• Recall Status: Terminated on January 03, 2012
• Recall Number: Z-0598-2012
• Recall Event ID: 60521
• 510(K)Number: K063696
• Product Classification: infusion pump - Product Code FRN
• Product: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
• Code Information: Product Code: 2M8161, Serial Number 12050019CC
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: one pump
• Distribution: Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN