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FDA (Device enforcement)Recalled 2024-03-19class ii

Medtronic Perfusion Systems: Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 681

Hazard

Potential for unsealed sterile packing.

Details from the source

Reason for recall: Potential for unsealed sterile packing. Distribution: Worldwide distribution. Quantity: 17221 units Lot/code info: a) Model Number 68120, GTIN 20613994879435, Lot Numbers: 2023041436; b) Model Number 68124, GTIN 00613994879417, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 00681490466349, Lot Numbers: 2023041441, 2023041448; b) Model Number 68124, GTIN 20613994879411, Lot Numbers: 2023041441, 2023041448, 202306C008; c) Model Number 68128, GTIN 00613994879394, Lot Numbers: 2023041040; c) Model Number 68128, GTIN 00681490466363, Lot Numbers: 2023041388; c) Model Number 68128, GTIN 20613994879398, Lot Numbers: 2023041040, 2023041388, 202306C010, 202306C011; d) Model Number 68130, GTIN 20613994879381, Lot Numbers: 2023041390, 202308C131; e) Model Number 68134, GTIN 20613994879367, Lot Numbers: 2023041431; f) Model Number 67312, GTIN 00613994879325, Lot Numbers: 2023041423; f) Model Number 67312, GTIN 00673978184180, Lot Numbers: 2023040074; f) Model Number 67312, GTIN 20613994879329, Lot Numbers: 2023040073, 2023040074, 2023041423; g) Model Number 67316, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; g) Model Number 67316, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; h) Model Number 67516, GTIN 00613994879301, Lot Numbers: 2023040076, 2023041416; h) Model Number 67516, GTIN 20613994879305, Lot Numbers: 2023040076, 2023041416, 202305C264; i) Model Number 66118, GTIN 00613994878526, Lot Numbers: 2023041014; i) Model Number 66118, GTIN 20613994878520, Lot Numbers: 2023041014, 2023041015; j) Model Number 67318, GTIN 00613994879295, Lot Number

UPC codes

20613994879435, 00613994879417, 00681490466349, 20613994879411, 00613994879394, 00681490466363, 20613994879398, 20613994879381, 20613994879367, 00613994879325, 00673978184180, 20613994879329, 00613994879301, 20613994879305, 00613994878526, 20613994878520, 00613994879295, 00673978184241, 20613994879299, 00613994879288, 00673978184258, 20613994879282, 00613994879233, 00673978184609, 20613994879237, 00613994878359, 20613994878353, 20613994878544, 00613994878366, 00673978184326, 20613994878360, 00673978184333, 20613994878377, 00673978165585, 20613994878384, 00613994878571, 20613994878575, 20613994878391, 00613994878588, 20613994878582

Source

Official record: FDA (Device enforcement)

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

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