FDA-Device2017-08-02Class II
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
Medtronic Perfusion Systems
Hazard
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Sold states
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.
Affected count
63053 (48180 US) (14873 OUS)
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2765-2017Don't want to check this manually?
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