AirFlow recall
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable…
Why was AirFlow recalled?
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134.
- Product
- AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable…
- Recalling firm
- Ventlab Corporation
- Quantity
- 14,602 total for all units
- Distribution
- Nationwide Distribution including IL, OH, NY and TN.
- Recall date
- November 7, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)