Z-0870-2021 Class II Terminated
FDA device recall Z-0870-2021 was initiated by Boston Scientific Corporation on December 15, 2020 and is designated Class II. 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. The recall status is terminated (terminated August 14, 2023). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- December 15, 2020
- Termination Date
- August 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution Pattern
US Nationwide distribution including in the states of Tulsa, OK.
Code Information
GTIN 08714729936176, Lot Number H1937249