—#37538

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Product code 2M8155, batch #50604

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide, and internationally to Brazil, Canada, Chile, China, Colombia, Hong Kong, Korea, New Zealand, Japan, Taiwan, Saudi Arabia and Turkey.

Timeline

Recall initiated: 2005-03-02
Posted by FDA: 2005-04-27
Terminated: 2006-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.