Reported Nov 7, 2012 · Terminated

AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce…

Ventlab Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ventlab Corporation · 155 Boyce Dr · Mocksville, NC · 27028-4187

Is this the product you have?

  • AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use
  • Manufactured byVentlab 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
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberProduct as published
AF1040MBProduct List 071012, , Lot #102091 and 102191
AF1040MBP, Lot #102106 and 102174
AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151
AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165
AF1140MB-P5, Lot #102145
AF1140MB-TAF1140MBP-T, Lot #102096 and , Lot #101666.
Amount recalled
14,602 total for all units

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

Stop using this product now

Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2013 · Data as of Sep 19, 6:10 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.