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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague 3 and 3 CX Infusion Pumps

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  Class 2 Device Recall Colleague 3 and 3 CX Infusion Pumps see related information
Date Initiated by Firm May 04, 2011
Date Posted July 13, 2011
Recall Status1 Terminated 3 on January 10, 2017
Recall Number Z-2796-2011
Recall Event ID 58806
510(K)Number K063696  
Product Classification Infustion pump - Product Code FRN
Product Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163.

Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
Code Information Product Code 2 M8153, serial numbers 9070872CT and 12120279CT;  Product Code 2M8163, serial numbers 14082199TC, 14090543TC, 13120195TC, 13120172TC, 13100660TC, 15041195TC, 11120467TC, 14082067TC, 12010398TC and 12010355TC
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		 The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
FDA Determined
Cause 2		 Employee error
Action Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost. Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.
Quantity in Commerce 12 pumps
Distribution Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and 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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