smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Device Recall #Z-1275-2024 — Class I — February 7, 2024
Recall Summary
| Recall Number | Z-1275-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | February 7, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smiths Medical ASD Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 2902 units |
Product Description
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
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.
Distribution Pattern
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 / Code Information
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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
Other Recalls from Smiths Medical ASD Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0147-2025 | Class II | smiths medical portex, Thermovent 1200, 15mm/22... | Jul 18, 2024 |
| Z-0145-2025 | Class II | smiths medical portex, Y' PIECE 15MM, REF 100/2... | Jul 18, 2024 |
| Z-0146-2025 | Class II | smiths medical portex, 'ORATOR' SPEAKING VALVE ... | Jul 18, 2024 |
| Z-0143-2025 | Class II | smiths medical portex, Nasopharyngeal Airway, S... | Jul 18, 2024 |
| Z-0144-2025 | Class II | smiths medical portex, 15mm Double Swivel Conne... | Jul 18, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.