Device evidence

device-recall:cfres:162686

Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

Official recall number

Z-1368-2018

Evidence summary

Product code: FAP
Recall status: Terminated
Event initiated: March 15, 2018
Root cause: Employee error
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1368-2018