[Recalled] AirFlow, Infant Resuscitator, AF3000 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 re
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | AirFlow, Infant Resuscitator, AF3000 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 associa |
|---|---|
| Brand / manufacturer | Ventlab Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0180-2013 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 11 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Ventlab Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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