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
000090857500009098930000909894000091137700009113780000911379000091386700009128900000913868000091543800009154390000915440000091544100009154420000915443000091704300009170450000917047000091704900009170510000921480000092148200009214840000921485000092149300009214940000921495000092149700009214980000924307000092430800009243090000924955000092431000009249530000924954000092781600009278180000927819000092782100009280930000928092000093129100009312920000931298000093129900009335830000933584000093428200009342830000934294000093429500009342970000934284000093607000009364230000939901000093990200009399030000939904
- 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.
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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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