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Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corpo

FDA device recall Z-0778-05 · posted 2005-04-27 · Terminated

Recall details

Recalling firm
Baxter Healthcare Corp.
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.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
FRN
Quantity affected
404 cables
Distribution
Nationwide, and internationally to Brazil, Canada, Chile, China, Colombia, Hong Kong, Korea, New Zealand, Japan, Taiwan, Saudi Arabia and Turkey.
Date initiated
2005-03-02
Date posted
2005-04-27
Date terminated
2006-05-23
Location
Round Lake, IL

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