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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter Colleague CX Infusion Pumps

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  Class 1 Device Recall Baxter Colleague CX Infusion Pumps see related information
Date Initiated by Firm August 15, 2007
Date Posted September 19, 2007
Recall Status1 Terminated 3 on February 21, 2008
Recall Number Z-1224-2007
Recall Event ID 39415
510(K)Number K063696  
Product Classification Infusion Pumps - Product Code FRN
Product Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161
Code Information product code 2M8161, serial numbers 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC
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		 Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
FDA Determined
Cause 2		 Other
Action The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.
Quantity in Commerce 42 pumps
Distribution Florida and California
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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