Device Recall mcompass 2channel Balloon Catheters

Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom

mcompass 2-channel Balloon Catheters || The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.