FDAFDA · Food and drugs·Recall number Z-1275-2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Published March 27, 2024 · Recall initiated: February 7, 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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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