FDAFDA · Food and drugs·Recall number Z-3090-2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Published October 2, 2024 · Recall initiated: May 31, 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
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- Serial Numbers: 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 236, 237, 238, 239, 240, 241, 242, 253, 254, 255, 256, 257, 258, 24224, 24225, 121045, 121046, 130135, 140738, 140739, 150206, 150207, 150208, 150209, 150210, 150211, 150212, 220977, 1002250, 1006901, 1006902, 1006903, 1006904, 1006905, 1006906, 1006907, 1006908, 1006909, 1006910, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163, 1009186, 1009187, 1009188, 1009189, 1009190, 1009230, 1009231, 1009232, 1009233, 1009234, 1009235, 1009236, 1009237, 1009238, 1009239, 1010143, 1010144, 1010145, 1010146, 1010147, 1010148, 1010149, 1010150, 1010151, 1010152, 1010167, 1010168, 1010169, 1010170, 1010171, 1010172, 1010173, 1010174, 1010175, 1010176, 1011339, 1011340, 1011341, 1011342, 1011343, 1011344, 1011345, 1011346, 1011347, 1011348, 1011349, 1011350, 1011351, 1011352, 1011353, 1011354, 1011355, 1011356, 1011357, 1011358, 1011452, 1011453, 1011454, 1011455, 1011456, 1012169, 1012170, 1012171, 1012172, 1012173, 1012174, 1012175, 1012176, 1012177, 1012178, 1012179, 1012180, 1012181, 1012182, 1012183, 1102229, 1102230, 1102231, 1102232, 1102330, 1102331, 1102332, 1102413, 1102414, 1103190, 1103191, 1103226, 1103249, 1103250, 1103251, 1103252, 1103253, 1103360, 1103361, 1103362, 1103363, 1103364, 1103388, 1103389, 1103390, 1103391, 1103392, 1104182, 1104183, 1104184, 1104185, 1104186, 1104187, 1104188, 1104189, 1104190, 1104191, 1104279, 1104280, 1104291, 1104292, 1104293, 1104320, 1104321, 1104322, 1104323, 1104324, 1105182, 1105209, 1105210, 1105211, 1105212, 1105213, 1105214, 1105215, 1105216, 1105217, 1105218, 1105296, 1105297, 1105298, 1105299, 1105300, 1105301, 1106124, 1106125, 1106126, 1106127, 1106128, 1106129, 1106221, 1106244, 1106245, 1106246, 1106247, 1106248, 1107142, 1107143, 1107144, 1107145, 1107146, 1107343, 1107344, 1107345, 1107346, 1108164, 1108165, 1108169, 1108171, 1108172, 1108173, 1108329, 1108330, 1109326, 1109327, 1110182, 1110183, 1110199, 1110200, 1110201, 1110202, 1111226, 1111227, 1111228, 1111229, 1111230, 1111231, 1111288, 1111289, 1111290, 1111291, 1111292, 1112157, 1112158, 1112159, 1112160, 1112161, 1112167, 1112168, 1112169, 1112170, 1112171, 1201142, 1201143, 1201166, 1201167, 1201179, 1201195, 1201196, 1201197, 1201198, 1201199, 1201286, 1201287, 1201288, 1201289, 1201290, 1202167, 1202168, 1202169, 1202170, 1202171, 1202172, 1202228, 1202229, 1202230, 1202288, 1202289, 1202290, 1202291, 1202292, 1203131, 1203140, 1203141, 1203142, 1203143, 1203144, 1203146, 1203172, 1203173, 1203174, 1203175, 1203176, 1203210, 1203217, 1203218, 1203219, 1203220, 1203221, 1203279, 1203280, 1203281, 1203282, 1203283, 1203311, 1203312, 1203313, 1203314, 1204059, 1204060, 1204061, 1204062, 1204063, 1204094, 1204095, 1204096, 1204097, 1204098, 1204099, 1204100, 1204101, 1204164, 1204165, 1204166, 1204167, 1204168, 1205062, 1205063, 1205064, 1205107, 1205108, 1205109, 1205110, 1205111, 1205127, 1205128, 1205129, 1205130, 1205131, 1205150, 1205151, 1205152, 1206121, 1206122, 1206178, 1206179, 1206180, 1206181, 1206182, 1206260, 1206261, 1206262, 1206263, 1206264, 1207174, 1207175, 1207176, 1207177, 1207178, 1207204, 1207205, 1207206, 1207207, 1207208, 1207255, 1207256, 1207257, 1207258, 1207259, 1207267, 1207268, 1207
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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