Boston Scientific Corporation Recall 87033
Description: 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 Recall 87033 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0870-2021 |
| Event ID | 87033 |
| Event Description | ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned. |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of Tulsa, OK. |
| Quantity | 5 units |
| Recall Reason | Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure. |
| Device Classification | 20210127 |
| Device Code Info | GTIN 08714729936176, Lot Number H1937249 |
| Center Classification Date | 20210115 |
| Recall Initiation Date | 20201215 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Visit |
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