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Recall Observatory FDA recall evidence

Device product

AirFlow, Small Adult Resuscitator, AF5000 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-0181-2013

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-0181-2013

Official wording

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

Code information: Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899.

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.