Medical device recalls Moderate risk

Covidien LLC recalls Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369

Recall date
April 23, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1904-2015
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 HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369

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