Medtronic Perfusion Systems: Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Numb

Hazard

Potential for unsealed sterile packing.

Details from the source

Reason for recall: Potential for unsealed sterile packing. Distribution: Worldwide distribution. Quantity: 13033 units Lot/code info: a) Model Number 80020, GTIN 20643169485703, Lot Numbers: 2023040597, 2023041061, 202305C247; b) Model Number 80220, GTIN 20643169485734, Lot Numbers: 2023031390, 2023040098, 202305C249, 202310C155; c) Model Number 82020, GTIN 20643169485536, Lot Numbers: 2023041063, 2023041396, 202305C253; d) Model Number 87120, GTIN 00673978187105, Lot Numbers: 2023040600; GTIN 20613994879114, Lot Numbers: 2023040600, 2023041066, 202306C018; e) Model Number 80222, GTIN 20643169485741, Lot Numbers: 2023041062, 202308C058; f) Model Number 87122, GTIN 00613994879103, Lot Numbers: 2023040601; GTIN 20613994879107, Lot Numbers: 2023040601, 2023041067, 202306C017; g) Model Number 87220, GTIN 00643169485563, Lot Numbers: 2023031282, 2023040602, 2023041068; GTIN 20643169485567, Lot Numbers: 2023031282, 2023031283, 2023031391, 2023040602, 2023041068, 202306C006, 202306C247; h) Model Number 87222, GTIN 00643169485570, Lot Numbers: 2023041408; GTIN 20643169485574, Lot Numbers: 2023041069, 2023041408, 202306C007; i) Model Number 77006, GTIN 20763000091013, Lot Numbers: 2023040943, 202306C056; j) Model Number 77206, GTIN 20763000091020, Lot Numbers: 2023041347, 202308C108; k) Model Number 77008, GTIN 20763000091105, Lot Numbers: 2023040944, 2023040946, 02306C020, 202308C084; l) Model Number 77010, GTIN 20763000091112, Lot Numbers: 2023041337, 202306C023; m) Model Number 77110, GTIN 00673978185989, Lot Numbers: 2023041342; GTIN 20763000091174, Lot Numbers: 2023041342, 202308C104; n) Model Number 77112, GTI

UPC codes

20643169485703, 20643169485734, 20643169485536, 00673978187105, 20613994879114, 20643169485741, 00613994879103, 20613994879107, 00643169485563, 20643169485567, 00643169485570, 20643169485574, 20763000091013, 20763000091020, 20763000091105, 20763000091112, 00673978185989, 20763000091174, 00673978186009, 20763000091181, 20763000135625, 20763000135632, 20763000135557, 00763000135676, 20763000135670, 20763000135564, 20643169485468, 00643169485938, 20643169485932, 20613994879701

Source

Official record: FDA (Device enforcement) ↗

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