ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter remova...
FDA Recall #Z-0870-2021 — Class II — December 15, 2020
Product Description
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Reason for Recall
Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.
Recalling Firm
Boston Scientific Corporation — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 units
Distribution
US Nationwide distribution including in the states of Tulsa, OK.
Code Information
GTIN 08714729936176, Lot Number H1937249
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated