Devices

Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.

Model / Serial
All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil.
Product Description
Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
Manufacturer
Sandhill Scientific, Inc
1 Event
- Recall of Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.

Manufacturer

Sandhill Scientific, Inc

Manufacturer Address
Sandhill Scientific, Inc, 9150 Commerce Center Cir Ste 500, Highlands Ranch CO 80129-1563
Source
USFDA

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