Reported Mar 27, 2024 · Ongoing

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

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?

  • smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Lot codes and dates
  • Serial Numbers

    3,621 of 3,621 codes

    • 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
Amount recalled
10140 units

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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.

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

Want the full recall guide?

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, 7:02 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.