Reported May 16, 2018 · Terminated

AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs Product Usage: The AirLife Resuscitation…

Vyaire Medical

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: Vyaire Medical · 75 N Fairway Dr · Vernon Hills, IL · 60061-1845

Is this the product you have?

  • AirLife Resuscitation, Adult, with mask, 40" oxygen
  • reservoir tubing 6/cs Product UsageThe AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own
Lot codes and dates
  • Part Number2K8005
  • Lots

    170 of 170 codes

    • 0000908575
    • 0000909893
    • 0000909894
    • 0000911377
    • 0000911378
    • 0000911379
    • 0000913867
    • 0000912890
    • 0000913868
    • 0000915438
    • 0000915439
    • 0000915440
    • 0000915441
    • 0000915442
    • 0000915443
    • 0000917043
    • 0000917045
    • 0000917047
    • 0000917049
    • 0000917051
    • 0000921480
    • 0000921482
    • 0000921484
    • 0000921485
    • 0000921493
    • 0000921494
    • 0000921495
    • 0000921497
    • 0000921498
    • 0000924307
    • 0000924308
    • 0000924309
    • 0000924955
    • 0000924310
    • 0000924953
    • 0000924954
    • 0000927816
    • 0000927818
    • 0000927819
    • 0000927821
    • 0000928093
    • 0000928092
    • 0000931291
    • 0000931292
    • 0000931298
    • 0000931299
    • 0000933583
    • 0000933584
    • 0000934282
    • 0000934283
    • 0000934294
    • 0000934295
    • 0000934297
    • 0000934284
    • 0000936070
    • 0000936423
    • 0000939901
    • 0000939902
    • 0000939903
    • 0000939904
Amount recalled
305,136 units

This recall covers 35 products

The agency filed one notice per product. You are reading one of them; the other 34 are below.

22 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.

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

Notice updated May 9, 2019 · Data as of Sep 19, 6:15 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.