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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:127524

Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Official recall number

Z-2099-2014

Evidence summary

Product code
DWF
Recall status
Terminated
Event initiated
May 23, 2014
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2099-2014