Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0778-05 · Posted 2005-04-27

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2005-03-02
Date Terminated2006-05-23
Product Quantity404 cables

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑