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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 July 05, 2011
Date Posted July 19, 2011
Recall Status1 Terminated 3 on January 20, 2012
Recall Number Z-2853-2011
Recall Event ID 59270
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, Medication Delivery Division. Product Code: 2M8161.

Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Code Information Product Code: 2M8161, Lot Numbers 13060235CC and 13090748CC
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		 While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.
FDA Determined
Cause 2		 Process control
Action Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up "URGENT PRODUCT RECALL" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.
Quantity in Commerce 2 units
Distribution Nationwide (USA) Distribution -- including the state of Pennsylvania.
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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