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FDA (Device enforcement)Recalled 2024-05-31class i

Smiths Medical ASD Inc.: paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 11244 units Lot/code info: 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

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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