|
|
|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
|
Z-1948-2020 - TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1949-2020 - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locall...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1950-2020 - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to local...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1955-2020 - TandemHeart pump is assembled into kits: TandemLife Kit
Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver ...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1952-2020 - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1953-2020 - 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 ...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1954-2020 - TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally de...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|
|
Z-1951-2020 - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del...
|
2
|
05/11/2020
|
FEI # 3002228812 Cardiac Assist, Inc
|