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U.S. Department of Health and Human Services

Class 3 Device Recall Configuration Transfer Cable

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  Class 3 Device Recall Configuration Transfer Cable see related information
Date Initiated by Firm March 02, 2005
Date Posted April 27, 2005
Recall Status1 Terminated 3 on May 23, 2006
Recall Number Z-0778-05
Recall Event ID 31266
Product Classification Pump, Infusion - Product Code FRN
Product Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL
Code Information Product code 2M8155, batch #50604
Recalling Firm/
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
The Configuration Tranfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it., not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.
FDA Determined
Cause 2
Action Recall letters dated 3/2/05 were sent to all customers receiving Configuration Transfer Cables between June and November 2004. The letters were sent to the attention of the Biomedical Engineer, and informed them that the thumbscrews were not manufactured according to Baxter''s specifications and were too narrow to secure the cable to the pump. The accounts were requested to return their Configuration Transfer Cables for replacement.
Quantity in Commerce 404 cables
Distribution Nationwide, and internationally to Brazil, Canada, Chile, China, Colombia, Hong Kong, Korea, New Zealand, Japan, Taiwan, Saudi Arabia and Turkey.
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.