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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 Recall
Colleague CX Infusion Pump
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on January 03, 2012
Recall Number Z-0598-2012
Recall Event ID 60521
Premarket Notification
510(K) Number
K063696 
Product Classification Pump, Infusion - 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, Illinois 60073
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
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