FDAFDA · Food and drugs·Recall number Z-3091-2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Published October 2, 2024 · Recall initiated: May 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- 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, 1408136, 1408137, 1408138, 1408139, 1408140, 1408141, 1408142, 1408143, 1408180, 1408181, 1408182, 1408183, 1408184, 1408185, 1408186, 1408187, 1408188, 1408189, 1408205, 1408206, 1408207, 1408208, 1408209, 1408210, 1408211, 1408212, 1408213, 1408214, 1408225, 1408226, 1408227, 1408228, 1408254, 1502242, 1504129, 1504130, 1505175, 1505176, 1505177, 1505178, 1505179, 1505180, 1505181, 1505182, 1505183, 1505184, 1505185, 1505186, 1505187, 1505188, 1505189, 1505190, 1505191, 1505192, 1505193, 1505194, 1505195, 1505196, 1505197, 1505198, 1505199, 1505200, 1509136, 1509272, 1509273, 1509311, 1510151, 1510254, 1510255, 1511190, 1511215, 1511216, 1511217, 1511218, 1511219, 1511220, 1511221, 1511222, 1601236, 1601237, 1601238, 1601239, 1601240, 1601241, 1601242, 1601243, 1601244, 1601245, 1601366, 1601367, 1601368, 1601369, 1601370, 1601371, 1601372, 1601373, 1601374, 1601375, 1601376, 1601377, 1601378, 1601379, 1601380, 1601381, 1601382, 1601383, 1602226, 1603294, 1605121, 1605122, 1605123, 1605124, 1605125, 1605126, 1605154, 1605155, 1605156, 1605157, 1605158, 1605159, 1605160, 1605161, 1605162, 1605163, 1605164, 1605165, 1605166, 1605167, 1605168, 1605169, 1605170, 1605171, 1606166, 1606167, 1606168, 1606189, 1606190, 1607203, 1607204, 1607205, 1607206, 1607207, 1607208, 1607209, 1607210, 1607211, 1608230, 1608231, 1608232, 1608233, 1608234, 1608235, 1608236, 1608237, 1608238, 1608239, 1609169, 1609170, 1609171, 1609172, 1609173, 1609174, 1609175, 1609176, 1609177, 1609178, 1609179, 1609180, 1609181, 1609182, 1609183, 1609184, 1610240, 1610241, 1610242, 1610243, 1610244, 1610245, 1610246, 1610247, 1610248, 1610249, 1610259, 1610260, 1610261, 1610262, 1610263, 1610264, 1610265, 1610266, 1610267, 1610268, 1610269, 1610270, 1610271, 1610272, 1610273, 1610274, 1610275, 1610276, 1610277, 1610278, 1611232, 1611233, 1611234, 1611235, 1611236, 1611237, 1611238, 1611239, 1611240, 1611298, 1611299, 1611300, 1701211, 1701212, 1701213, 1701214, 1701215, 1701216, 1701217, 1701218, 1701219, 1701220, 1701221, 1701224, 1701225, 1701226, 1701227, 1701228, 1701229, 1701230, 1703061, 1703062, 1703082, 1703083, 1703084, 1703085, 1703086, 1703087, 1703088, 1703150, 1703151, 1703217, 1703218, 1703219, 1703220, 1703221, 1703222, 1703223, 1703224, 1703225, 1703226, 1703229, 1703230, 1703231, 1703232, 1703233, 1703234, 1703235, 1703236, 1703237, 1703238, 1703239, 1703240, 1703241, 1704100, 1704101, 1704102, 1704103, 1704104, 1704105, 1704106, 1704107, 1704108, 1704109, 1704122, 17041
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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