FDAFDA · Food and drugs·Recall number Z-0178-2013
Ventlab Premium Small Adult Resuscitator, 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.
Published November 7, 2012 · Recall initiated: July 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ventlab Corporation
- Distributor
- Nationwide Distribution including IL, OH, NY and TN.
- Lot
- Product Code: VN500MX, Lot #102194.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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