FDA recall Z-1952-2020

Product

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 deliver an anticoagulant through the infusion system.

Reason for recall

Failure to prime due to an assembly error

Distribution

US Nationwide distributions.

Key facts

Status

Terminated

Initiation date

2020-03-06

Report date

2020-05-20

Termination date

2020-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1952-2020