Medtronic Perfusion Systems recalls DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde…

Recall date

June 22, 2017

Source

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

Recall number

Z-2765-2017

FDA classification

Class II

Brand / firm

Medtronic Perfusion Systems

Sold / distributed

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romani…

Why it was recalled

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

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

What was recalled

DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae