Ventlab AirFlow Infant Resuscitator Recalled for Inlet Valve Leakage
Ventlab is recalling 14,602 AirFlow Infant Resuscitators because the inlet valve may leak air during compressions, potentially compromising respiratory support.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class I, which mandates a minimum score of 4 per the rubric. Additionally, the defect involves a critical life-support device where failure could lead to serious injury.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the AirFlow Infant Resuscitator, AF3000 Series. These single-use disposable resuscitators are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. The recall covers specific product codes and lot numbers, including AF3100MB-M1, AF3140MB-I, and AF3140MB-K, among others.
The recall was initiated due to a potential volume leakage through the inlet valve during compressions of the resuscitator bag. This defect may affect the device's ability to deliver adequate respiratory support to infants.
The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Healthcare facilities and consumers who have these specific lot numbers should stop using the devices and contact Ventlab Corporation for instructions on return or replacement.
The recalled product
- Product
- AirFlow, Infant Resuscitator, AF3000 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…
- 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 (20)
- Product Code: AF3100MB-M1
- Lot #102185
- AF3140MB-I
- Lot #102129 and AF3140MB-K
- Lot #101592
- 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
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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