Agency classClass IOur severity:Severe FDA (Devices)·Z-3091-2024·Announced 2024-10-02

Smiths Medical Recalls paraPAC 300 Ventilator Kits Due to Connector Issue

Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this recall as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).

Plain-English summary

Smiths Medical ASD Inc. is recalling 3,182 units of the paraPAC 300 ventilator kit without internal PEEP and CPAP (Item Number P300N). The recall is due to a potential issue where the patient outlet connector may loosen or detach from the ventilator. This defect can impact the active ventilation function of the device.

The affected units were distributed worldwide. The recall covers specific serial numbers listed in the official FDA record Z-3091-2024. No illnesses or injuries have been reported in the source text.

Healthcare facilities and users should check their inventory for the affected serial numbers and contact Smiths Medical for instructions on how to proceed. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

The recalled product

Product: paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Ventilator
Hazard: device-malfunction
ventilation-failure
Affected units: 3,182

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Serial Numbers: 1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Smiths Medical ASD Inc.

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