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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:172567

2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Official recall number

Z-1699-2019

Evidence summary

Product code
KDI
Recall status
Terminated
Event initiated
April 03, 2019
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1699-2019

Field note

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