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

All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.

Gastroenterology-Urology Devices

2

No

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.

Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.