FDA-Device2020-05-20Class II
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Cardiac Assist, Inc
Hazard
Failure to prime due to an assembly error
Sold states
US Nationwide distributions.
Affected count
6
Manufactured in
240 Alpha Dr, N/A, Pittsburgh, PA, United States
Products
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1953-2020Don't want to check this manually?
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