FDA-Device2013-07-17Class II
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Boston Scientific Corporation
Hazard
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Sold states
Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
Affected count
27
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1672-2013Don't want to check this manually?
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