Medtronic Perfusion Systems Recall 94274
Description: Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Medtronic Perfusion Systems Recall 94274 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1803-2024 |
| Event ID | 94274 |
| Event Description | Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 1410 units |
| Recall Reason | Potential for unsealed sterile packing. |
| Device Classification | 20240522 |
| Device Code Info | a) Model Numbers: 31100, GTIN 20885074257116, Lot Numbers: 2023081208; b) Model Numbers: 31125, GTIN 20885074257406, lot Numbers: 2023041455, 202306C205; c) Model Numbers: 31200, GTIN 00885074257433, Lot Numbers: 2023040542; c) Model Numbers: 31200, GTIN 20885074257437, Lot Numbers: 2023040542, 2023041002, 202305C173 |
| Center Classification Date | 20240510 |
| Recall Initiation Date | 20240319 |
| Recalling Firm | Medtronic Perfusion Systems |
| Initial Notification | Letter |
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