Recall archive / FDA device enforcement

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS — FDA record Z-1275-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 7, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
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.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: 2902 units
Agency-reported status: Ongoing
Source record identifier: Z-1275-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Serial Numbers: 70085, 70091, 70096, 70097, 70101, 70103, 70111, 70112, 70114, 70119, 70142, 70171, 70299, 1007188, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223, 1304224, 1304225, 1304226, 1304227, 1304228, 1304229, 1304230, 1304231, 1304232, 1304233, 1304234, 1304235, 1304236, 1304237, 1305192, 1305193, 1305194, 1305195, 1305196, 1305197, 1305198, 1305199, 1305200, 1305201, 1310001, 1310129, 1311132, 1311133, 1311134, 1311135, 1311136, 1311137, 1311140, 1311141, 1401228, 1403142, 1406374, 1406375, 1406376, 1406377, 1406378, 1406379, 1406380, 1406381, 1406382, 1406383, 1407291, 1407292, 1407293, 1407294, 1407295, 1407296, 1407297, 1407298, 1407299, 1407300, 1407430, 1407431, 1407432, 1407433, 1407434, 1407442, 1407443, 1408134, 1408135, 1408136, 1408137, 1408138, 1408139, 1408140, 1408141, 1408142, 1408143, 1408180, 1408181, 1408182, 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Label field

Details supplied by the agency

Lot, code or applicability

Serial Numbers: 70085, 70091, 70096, 70097, 70101, 70103, 70111, 70112, 70114, 70119, 70142, 70171, 70299, 1007188, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223, 1304224, 1304225, 1304226, 1304227, 1304228, 1304229, 1304230, 1304231, 1304232, 1304233, 1304234, 1304235, 1304236, 1304237, 1305192, 1305193, 1305194, 1305195, 1305196, 1305197, 1305198, 1305199, 1305200, 1305201, 1310001, 1310129, 1311132, 1311133, 1311134, 1311135, 1311136, 1311137, 1311140, 1311141, 1401228, 1403142, 1406374, 1406375, 1406376, 1406377, 1406378, 1406379, 1406380, 1406381, 1406382, 1406383, 1407291, 1407292, 1407293, 1407294, 1407295, 1407296, 1407297, 1407298, 1407299, 1407300, 1407430, 1407431, 1407432, 1407433, 1407434, 1407442, 1407443, 1408134, 1408135, 1408136, 1408137, 1408138, 1408139, 1408140, 1408141, 1408142, 1408143, 1408180, 1408181, 1408182, 1408183, 1408184, 1408185, 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2102044, 2...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 27, 2024
Recall initiation date: Feb 7, 2024
Center classification date: Mar 19, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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