Covidien LLC recalls Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated…

Recall date

April 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1850-2015

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Nether…

Why it was recalled

Catheters may not meet antimicrobial specification

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.