FDA-Device2021-01-27Class II
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Boston Scientific Corporation
Hazard
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
Sold states
US Nationwide distribution including in the states of Tulsa, OK.
Affected count
5 units
Manufactured in
4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, United States
Products
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0870-2021Don't want to check this manually?
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