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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:113066

Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.

Official recall number

Z-0071-2013

Evidence summary

Product code
KRI
Recall status
Terminated
Event initiated
October 02, 2009
Root cause
Labeling design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0071-2013