510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1275-2024Class I

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

Abbott Medical / initiated 2024-02-07 / Open, Classified
FDA source (opens on fda.gov)

Smiths Medical ASD Inc. began a recall of smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1275-2024
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Abbott Medical
Product
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
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.
FDA root cause
Under Investigation by firm
Action
Smiths medical issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 02/07/2024 via letter using traceable means. The notice explained the issue with the device, potential risk to the patient, and requested the following actions be taken: "There is no need to return or discontinue using your paraPAC plus, at this time. When using the device, all instructions, including warnings and cautions in the User Manual Doc. numbers (10018833-003 and/or 10026347-002) must be followed with heightened awareness. This is inclusive, but not limited to the following: " Constant monitoring of the patient. " Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography. " All pre-use checks must be performed before each use. " Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction. If the paraPac plus ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation." " Customer Required Actions: 1. Please identify all paraPAC plusTM units in your possession. 2. Share this recall notification with all potential users of the devices and if the devices are used at another location. 3. Complete and return the attached Customer Response Form to [email protected]. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]." For questions about this Field Correction Notice, contact your sales representative or call 763-383-3072.
Quantity in commerce
2902 units
Distribution
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.
Product codes and lots
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2303026, 2303027, 2303028, 2303029, 2303030, 2303031, 2303032, 2303033, 2303034, 2303035, 2303036, 2303037, 3540877, 1605167A, 2106048, 2106049, 2106050, 2106051, 2106052, 2106053, 2106054, 2106055, 2106056, 2106057, 2106058, 2106059, G;10328, GC00001, GC00002, GC00003, GC00004, GC00005, GC00006, GC00007, GC00008, GC00009, GC00010, GC00011, GC00012, GC00013, GC00014, GC00015, GC00016, GC00017, GC00018, GC00019, GC00020, GC00021, GC00022, GC00023, GC00024, GC00025, GC00026, GC00027, GC00028, GC00029, GC00030, GC00031, GC00032, GC00033, GC00034, GC00035, GC00036, GC00037, GC00038, GC00039, GC00040, GC00041, GC00042, GC00043, GC00044, GC00045, GC00046, GC00047, GC00048, GC00049, GC00050, GC00051, GC00052, GC00053, GC00054, GC00055, GC00056, GC00057, GC00058, GC00059, GC00060, GC00061, GC00062, GC00063, GC00064, GC00065, GC00066, GC00067, GC00068, GC00069, GC00070, GC00071, GC00072, GC00073, GC00074, GC00076, GC00077, GC00078, GC00079, GC00080, GC00081, GC00082, GC00083, GC00085, GC00086, GC00087, GC00088, GC00089, GC00090, GC00091, GC00092, GC00093, GC00094, GC00095, GC00096, GC00097, GC00098, GC00099, GC00100, GC00101, GC00102, GC00103, GC00104, GC00105, GC00106, GC00107, GC00108, GC00109, GC00110, GC00111, GC00112, GC00113, GC00114, GC00115, GC00116, GC00117, GC00118, GC00119, GC00120, GC00121, GC00122, GC00123, GC00124, GC00125, GC00126, GC00127, GC00128, GC00129, GC00130, GC00131, GC00132, GC00133, GC00134, GC00135, GC00136, GC00137, GC00138, GC00139, GC00140, GC00141, GC00142, GC00143, GC00144, GC00145, GC00146, GC00147, GC00148, GC00149, GC00150, GC00151, GC00152, GC00153, GC00154, GC00155, GC00156, GC00157, GC00158, GC00159, GC00160, GC00161, GC00162, GC00163, GC00164, GC00165, GC00166, GC00167, GC00168, GC00169, GC00170, GC00171, GC00172, GC00173, GC00174, GC00175, GC00176, GC00177, GC00178, GC00179, GC00180, GC00181, GC00182, GC00183, GC00184, GC00185, GC00186, GC00187, GC00188, GC00189, GC00190, GC00191, GC00192, GC00193, GC00194, GC00195, 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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1275-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1274-2024Class IOngoingVoluntary: Firm initiated
Z-1275-2024Class IOngoingVoluntary: Firm initiated