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FDA (Device enforcement)Recalled 2024-05-31class i

Smiths Medical ASD Inc.: paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

Hazard

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

Details from the source

Reason for recall: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function. Distribution: Worldwide distribution. Quantity: 3182 units Lot/code info: Serial Numbers: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 234, 235, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 70085, 70091, 70096, 70097, 70101, 70103, 70111, 70112, 70114, 70119, 70142, 70171, 70299, 1007188, 1102432, 1102433, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210164, 1210165, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223, 1304224, 1304225, 1304226, 1304227, 1304228, 1304229, 1304230, 1304231, 1304232, 1304233, 1304234, 1304235, 1304236, 1304237, 1305192, 1305193, 1305194, 1305195, 1305196, 1305197, 1305198, 1305199, 1305200, 1305201, 1310001, 1310129, 1311132, 1311133, 1311134, 1311135, 1311136, 1311137, 1311138, 1311139, 1311140, 1311141, 1401228, 1403142, 1406374, 1406375, 1406376, 1406377, 1406378, 1406379, 1406380, 1406381, 1406382, 1406383, 1407291, 1407292, 1407293, 1407294, 1407295, 1407296, 1407297, 1407298, 1407299, 1407300, 1407430, 1407431, 1407432, 1407433, 1407434, 1407441, 1407442, 1407443, 1407444, 1408134, 1408135,

Source

Official record: FDA (Device enforcement)

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

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