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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185176

B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

Official recall number

Z-0965-2021

Evidence summary

Product code
FGE
Recall status
Terminated
Event initiated
January 04, 2021
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0965-2021