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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:113707

24 Fr 8mm Sft Flow Straight The Sarns 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-0458-2013

Evidence summary

Product code
DWF
Recall status
Terminated
Event initiated
November 21, 2012
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0458-2013