Reported Oct 2, 2024 · Ongoing

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

Smiths Medical ASD Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

  • paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
Lot codes and dates
  • Serial Numbers

    3,183 of 3,183 codes

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Amount recalled
3182 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.