Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0778-05

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

Baxter Healthcare Corporation / initiated 2005-03-02 / Terminated

Baxter Healthcare Corp. began a recall of Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL on . The reason FDA records is "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0778-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
Product
Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL
Product code
FRN Pump, Infusion
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 root cause
Other
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.
Product codes and lots
Product code 2M8155, batch #50604