FDA-Device2012-11-07Class I
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Ventlab Corporation
Hazard
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Sold states
Nationwide Distribution including IL, OH, NY and TN.
Affected count
14,602 total for all units
Manufactured in
155 Boyce Dr, N/A, Mocksville, NC, United States
Products
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2013Don't want to check this manually?
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