Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device intended for life-support (respiratory support during apnea) where a functional defect (leakage) poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of AirFlow, Small Adult Resuscitator, AF5000 Series, Single use. The recall covers specific product codes and lot numbers, including AF5140MBPWTD5, AF5140MB-T, AFD5140MB-T, AF5140MBS-I, AF5140MB-ST, AF5140MBS, and AF5140MBS-R.
The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. These devices are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- 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 reversib
- Manufacturer
- Ventlab Corporation
- Affected units
- 14,602
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Part of a larger recall action
This product is one of 12 recalled by Ventlab Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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