Devices

Device Recall AirFlow, Small Adult Resuscitator

Model / Serial
Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including IL, OH, NY and TN.
Product Description
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.
Manufacturer
Ventlab Corporation
1 Event
- Recall of Device Recall AirFlow, Small Adult Resuscitator

Manufacturer

Ventlab Corporation

Manufacturer Address
Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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