Medtronic Perfusion Systems: Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearV

Hazard

Potential for unsealed sterile packing.

Details from the source

Reason for recall: Potential for unsealed sterile packing. Distribution: Worldwide distribution. Quantity: 1410 units Lot/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

UPC codes

20885074257116, 20885074257406, 00885074257433, 20885074257437

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.