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

Summary

The FDA issued a Class I for smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, RE by Smiths Medical ASD Inc.. Reason: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow .

Details

Product Description

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

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GC00196, GC00197, GC00198, GC00199, GC00200, GC00201, GC00202, GC00203, GC00204, GC00205, GC00206, GC00207, GC00208, GC00209, GC00210, GC00211, GC00212, GC00213, GC00214, GC00215, GC00216, GC00217, GC00218, GC00219, GC00220, GC00221, GC00222, GC00223, GC00224, GC00225, GC00226, GC00227, GC00228, GC00229, GC00230, GC00231, GC00232, GC00233, GC00234, GC00235, GC00236, GC00237, GC00238, GC00239, GC00240, GC00241, GC00242, GC00243, GC00244, GC00245, GC00246, GC00247, GC00248, GC00249, GC00250, GL10006, GL10007, GL10008, GL10009, GL10010, GL10011, GL10012, GL10013, GL10014, GL10016, GL10017, GL10018, GL10019, GL10021, GL10022, GL10023, GL10024, GL10025, GL10026, GL10027, GL10028, GL10035, GL10036, GL10037, GL10038, GL10039, GL10040, GL10041, GL10042, GL10043, GL10044, GL10045, GL10046, GL10047, GL10048, GL10049, GL10050, GL10051, GL10052, GL10053, GL10054, GL10055, GL10056, GL10057, GL10058, GL10059, GL10060, GL10061, GL10062, GL10063, GL10064, GL10065, GL10066, GL10067, GL10068, GL10069, GL10070, GL10071, GL10072, GL10073, GL10074, GL10075, GL10076, GL10077, GL10078, GL10080, GL10081, GL10082, GL10083, GL10084, GL10085, GL10086, GL10087, GL10088, GL10089, GL10090, GL10091, GL10092, GL10093, GL10094, GL10095, GL10096, GL10097, GL10098, GL10099, GL10100, GL10101, GL10102, GL10103, GL10104, GL10105, GL10106, GL10107, GL10108, GL10109, GL10110, GL10111, GL10112, GL10113, GL10114, GL10115, GL10116, GL10117, GL10118, GL10119, GL10120, GL10121, GL10122, GL10123, GL10124, GL10125, GL10126, GL10127, GL10128, GL10129, GL10130, GL10131, GL10132, GL10133, GL10134, GL10135, GL10136, GL10137, GL10138, GL10139, GL10140, GL10141, GL10142, GL10143, GL10144, GL10145, GL10146, GL10147, GL10148, GL10149, GL10150, GL10151, GL10152, GL10153, GL10154, GL10155, GL10156, GL10157, GL10158, GL10159, GL10160, GL10161, GL10162, GL10163, GL10164, GL10165, GL10166, GL10167, GL10168, GL10169, GL10170, GL10171, GL10172, GL10173, GL10174, GL10175, GL10176, GL10177, GL10178, GL10179, GL10180, GL10181, GL10182, GL10183, GL10184, GL10185, GL10186, GL10187, GL10188, GL10189, GL10190, GL10191, GL10192, GL10193, GL10194, GL10195, GL10196, GL10197, GL10198, GL10199, GL10200, GL10201, GL10202, GL10203, GL10204, GL10205, GL10206, GL10207, GL10208, GL10209, GL10210, GL10211, GL10212, GL10213, GL10214, GL10215, GL10216, GL10217, GL10218, GL10219, GL10220, GL10221, GL10222, GL10223, GL10224, GL10225, GL10226, GL10227, GL10228, GL10229, GL10230, GL10231, GL10232, GL10233, GL10234, GL10235, GL10236, GL10237, GL10238, GL10239, GL10240, GL10241, GL10242, GL10243, GL10244, GL10245, GL10246, GL10247, GL10248, GL10249, GL10250, GL10251, GL10252, GL10253, GL10254, GL10255, GL10256, GL10257, GL10258, GL10259, GL10260, GL10261, GL10262, GL10263, GL10264, GL10265, GL10266, GL10267, GL10268, GL10269, GL10270, GL10271, GL10272, GL10273, GL10274, GL10275, GL10276, GL10277, GL10278, GL10279, GL10280, GL10281, GL10282, GL10283, GL10284, GL10285, GL10286, GL10287, GL10288, GL10289, GL10290, GL10291, GL10292, GL10293, GL10294, GL10295, GL10296, GL10297, GL10298, GL10299, GL10300, GL10301, GL10302, GL10303, GL10304, GL10305, GL10306, GL10307, GL10308, GL10309, GL10310, GL10311, GL10312, GL10313, GL10314, GL10315, GL10316, GL10317, GL10318, GL10319, GL10320, GL10321, GL10322, GL10323, GL10324, GL10325, GL10326, GL10327, GL10328, GL10329, GL10330, GL10331, GL10332, GL10333, GL10334, GL10335, GL10336, GL10337, GL10338, GL10339, GL10340, GL10341, GL10342, GL10343, GL10344, GL10345, GL10346, GL10347, GL10348, GL10349, GL10350, GL10351, GL10352, GL10353, GL10354, GL10355, GL10356, GL10357, GL10358, GL10359, GL10360, GL10361, GL10362, GL10363, GL10364, GL10365, GL10366, GL10367, GL10368, GL10369, GL10370, GL10371, GL10372, GL10373, GL10374, GL10375, GL10376, GL10377, GL10378, GL10379, GL10380, GL10381, GL10382, GL10383, GL10384, GL10385, GL10386, GL10387, GL10388, GL10389, GL10390, GL10391, GL10392, GL10393, GL10394, GL10395, GL10396, GL10397, GL10398, GL10399, GL10400, GL10401, GL10402, GL10403, GL10404, GL10405, GL10406, GL10407, GL10408, GL10409, GL10410, GL10411, GL10412, GL10413, GL10414, GL10415, GL10416, GL10417, GL10418, GL10421, GL10422, GL10423, GL10424, GL10425, GL10426, GL10427, GL10428, GL10429, GL10430, GL10431, GL10432, GL10433, GL10434, GL10435, GL10436, GL10437, GL10438, GL10439, GL10440, GL10441, GL10442, GL10443, GL10444, GL10445, GL10446, GL10447, GL10448, GL10449, GL10450, GL10451, GL10452, GL10453, GL10454, GL10455, GL10456, GL10457, GL10458, GL10459, GL10460, GL10461, GL10462, GL10463, GL10464, GL10465, GL10466, GL10467, GL10468, GL10469, GL10470, GL10471, GL10473, GL10474, GL10475, GL10476, GL10477, GL10478, GL10479, GL10480, GL10481, GL10482, GL10483, GL10484, GL10485, GL10486, GL10487, GL10488, GL10489, GL10491, GL10492, GL10493, GL10583, GL19479, RF20267, RF70003, RF70004, RF70005, RF70006, RF70007, RF70009, RF70010, RF70011, RF70012, RF70013, RF70014, RF70015, RF70016, RF70018, RF70019, RF70020, RF70021, RF70023, RF70024, RF70025, RF70026, RF70027, RF70028, RF70030, RF70031, RF70033, RF70034, RF70035, RF70036, RF70037, RF70038, RF70039, RF70040, RF70041, RF70042, RF70043, RF70044, RF70045, RF70046, RF70047, RF70048, RF70049, RF70050, RF70051, RF70052, RF70053, RF70054, RF70055, RF70056, RF70057, RF70058, RF70059, RF70060, RF70061, RF70062, RF70063, RF70064, RF70065, RF70066, RF70067, RF70068, RF70069, RF70070, RF70071, RF70072, RF70073, RF70074, RF70075, RF70076, RF70077, RF70078, RF70079, RF70080, RF70081, RF70082, RF70084, RF70085, RF70086, RF70087, RF70088, RF70089, RF70090, RF70091, RF70092, RF70093, RF70094, RF70095, RF70096, RF70097, RF70098, RF70099, RF70100, RF70101, RF70102, RF70103, RF70104, RF70105, RF70106, RF70107, RF70108, RF70109, RF70110, RF70111, RF70112, RF70113, RF70114, RF70116, RF70117, RF70118, RF70119, RF70121, RF70122, RF70123, RF70124, RF70128, RF70129, RF70130, RF70131, RF70132, RF70133, RF70134, RF70135, RF70136, RF70137, RF70138, RF70139, RF70140, RF70141, RF70142, RF70143, RF70144, RF70145, RF70146, RF70147, RF70148, RF70149, RF70150, RF70151, RF70152, RF70153, RF70154, RF70155, RF70156, RF70157, RF70158, RF70159, RF70160, RF70161, RF70162, RF70164, RF70165, RF70166, RF70167, RF70168, RF70169, RF70171, RF70173, RF70174, RF70175, RF70176, RF70177, RF70179, RF70180, RF70181, RF70182, RF70183, RF70184, RF70185, RF70186, RF70187, RF70188, RF70189, RF70190, RF70191, RF70192, RF70193, RF70194, RF70195, RF70196, RF70197, RF70199, RF70200, RF70203, RF70204, RF70206, RF70208, RF70209, RF70210, RF70211, RF70212, RF70213, RF70214, RF70215, RF70216, RF70217, RF70218, RF70219, RF70220, RF70221, RF70222, RF70223, RF70224, RF70225, RF70226, RF70227, RF70228, RF70229, RF70230, RF70231, RF70232, RF70233, RF70234, RF70235, RF70236, RF70237, RF70238, RF70239, RF70240, RF70241, RF70242, RF70243, RF70244, RF70245, RF70247, RF70248, RF70249, RF70250, RF70251, RF70252, RF70253, RF70254, RF70256, RF70257, RF70258, RF70259, RF70260, RF70261, RF70264, RF70267, RF70268, RF70269, RF70270, RF70271, RF70272, RF70273, RF70274, RF70275, RF70276, RF70278, RF70279, RF70280, RF70281, RF70282, RF70283, RF70284, RF70287, RF70289, RF70292, RF70293, RF70296, RF70298

Quantity Affected: 2902 units

Reason for Recall

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-02-07

Company