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Recall Observatory FDA recall evidence

Device product

AirFlow Resuscitator, Adult Resuscitator, AF1000 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 associated with cardiopulmonary arrest.

Z-0175-2013

July 11, 2012

Class I

Product summary

Firm
Ventlab Corporation
Event
Event 63347
Status
Terminated
Classification
Class I
Quantity
14,602 total for all units
Official record key
device-enforcement:Z-0175-2013

Official wording

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

Code information: Product List 071012, Product Code: AF1040MB, 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; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666.

Distribution pattern: Nationwide Distribution including IL, OH, NY and TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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