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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:112481

Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.

Official recall number

Z-0049-2013

Evidence summary

Product code
KFM
Recall status
Terminated
Event initiated
September 25, 2012
Root cause
Component design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0049-2013