Medtronic Perfusion Systems recalls DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the…

Recall date

June 22, 2017

Source

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

Recall number

Z-2766-2017

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 Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours