FDA Device recall Z-1274-2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Device
Class I
ongoing
Published 2024-03-27

On 2024-03-27 the FDA classified a Class I recall of smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS by Smiths Medical Asd, citing 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 cycli….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1274-2024
Classification	Class I
Status	ongoing
Initiated	2024-02-07
Published	2024-03-27
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	US

Product

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

Reason

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.

Identifiers

code_info	Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163,… Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 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, 1010170, 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, 1103362, 1103388, 1103389, 1103390, 1103391, 1103392, 1104182, 1104183, 1104184, 1104185, 1104186,

code_info

Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163,…

Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 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, 1010170, 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, 1103362, 1103388, 1103389, 1103390, 1103391, 1103392, 1104182, 1104183, 1104184, 1104185, 1104186,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1274-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.