Devices

Device Recall mcompass 2channel Balloon Catheters

Model / Serial
Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
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
Product Description
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.
Manufacturer
Medspira, Llc
1 Event
- Recall of Device Recall mcompass 2channel Balloon Catheters

Manufacturer

Medspira, Llc

Manufacturer Address
Medspira, Llc, 2718 Summer St NE, Minneapolis MN 55413-2820
Manufacturer Parent Company (2017)
Medspira Llc
Source
USFDA

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