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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1275-2024

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

Publicado el 27 de marzo de 2024 · Inicio del retiro: 7 de febrero de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Smiths Medical ASD Inc.
Distribuidor
Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Singapore, Slovakia, Slovenia, Saudi Arabia, South Africa, Spain, Sweden, Tawain, Province of China, Thailand, Trinidad and Tobago, Turkey, United Kingdom and Viet Nam.
Lote
Serial Numbers: 70085, 70091, 70096, 70097, 70101, 70103, 70111, 70112, 70114, 70119, 70142, 70171, 70299, 1007188, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 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, 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, 1407442, 1407443, 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, 1510254, 1510255, 1511190, 1511215, 1511216, 1511217, 1511218, 1511219, 1511220, 1511221, 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, 1603294, 1605121, 1605122, 1605123, 1605124, 1605125, 1605126, 1605155, 1605156, 1605158, 1605159, 1605161, 1605162, 1605163, 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, 1609181, 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, 1704123, 1704124, 1704125, 1704126, 1704127, 1704128, 1704129, 1704130, 1704131, 1704132, 1705111, 1709167, 1709168, 1709169, 1709170, 1710098, 1710099, 1710100, 1710101, 1710102, 1710103, 1710104, 1710105, 1710106, 1710107, 1710109, 1710110, 1710111, 1710112, 1710113, 1710114, 1710115, 1710116, 1710117, 1710118, 1710121, 1710122, 1710123, 1710124, 1710125, 1710126, 1710127, 1710128, 1710129, 1710130, 1710139, 1710140, 1710141, 1710142, 1710143, 1710144, 1710145, 1710146, 1711120, 1711121, 1711122, 1711123, 1711124, 1711125, 1711126, 1711127, 1711128, 1711129, 1711130, 1711131, 1711132, 1711145, 1711146, 1711147, 1711148, 1711149, 1711150, 1711151, 1711152, 1711153, 1711154, 1711155, 1711156, 1711157, 1712
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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