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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague CX Volumetric Infusion Pump

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  Class 2 Device Recall Colleague CX Volumetric Infusion Pump see related information
Date Initiated by Firm December 01, 2010
Date Posted January 21, 2011
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-0931-2011
Recall Event ID 57515
510(K)Number K063696  
Product Classification Pump, infusion - Product Code FRN
Product Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
Code Information Product Code: 2M8161, serial number 15030799CC
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 the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
FDA Determined
Cause 2		 Employee error
Action Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.
Quantity in Commerce 1 pump
Distribution Texas
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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