FDA-Device2013-07-17Class II
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 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
15 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief