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Class 2 Device Recall Colleague CX Infusion Pump |
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Date Initiated by Firm |
July 22, 2011 |
Date Posted |
August 11, 2011 |
Recall Status1 |
Terminated 3 on November 09, 2011 |
Recall Number |
Z-3007-2011 |
Recall Event ID |
59448 |
510(K)Number |
K063696
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Product Classification |
Pump, infusion - Product Code FRN
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Product |
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Deerfield, IL. Product Code: 2M8161.
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, Serial Number 12010746CC |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.
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FDA Determined Cause 2 |
Process design |
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; promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com, and forward this communication to the pump owner as appropriate, if they distributed the pump to another facility or if they are dealers, wholesalers, or distributors/resellers.
The letter states "Upon receipt of the returned device, Baxter will perform required testing on the affected COLLEAGUE pump for which you have indicated there is continuing medical necessity. Should Baxter find any issues during testing, Baxter will address those issues through repair or service prior to returning the pump to you at no charge".
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: MN only. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
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