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[Recalled] Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonl

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductSafe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, 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.
Brand / manufacturerVentlab Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0176-2013
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date11 July 2012
EAN / barcode101604101657

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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