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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 August 11, 2011
Recall Status1 Terminated on October 19, 2011
Recall Number Z-3008-2011
Recall Event ID 59445
Premarket Notification
510(K) Number
K063696 
Product Classification Pump, Infusion - Product Code FRN
Product Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161
Code Information Product Code: 2M8161, Serial Number 12091459CC
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
A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com. If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.
Quantity in Commerce 1 pump
Distribution Nationwide distribution: Missouri only.
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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