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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague CX Infusion Pump

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  Class 2 Device Recall Colleague CX Infusion Pump see related information
Date Initiated by Firm May 08, 2009
Date Posted January 11, 2012
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BAXTERHEALTHCARE, INC.
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