FDA-Device2017-08-02Class II
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
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 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2766-2017Don't want to check this manually?
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