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Medtronic Perfusion Systems recalls DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde
Recalled August 2, 2017 · FDA recall Z-2765-2017 · Medtronic Perfusion Systems
Hazard
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. · FDA Class II
Units
63053 (48180 US) (14873 OUS)
Sold at
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, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
Description
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Product
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
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →