Ventlab AirFlow Resuscitator Recalled for Inlet Valve Leakage
Ventlab Corporation is recalling 14,602 AirFlow Resuscitators due to possible volume leakage through the inlet valve during bag compressions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Ventlab Corporation is recalling 14,602 units of the AirFlow Resuscitator, Adult Resuscitator, AF1000 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 is being conducted because of possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to provide adequate respiratory support.
The affected products were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. Specific product codes and lot numbers are listed in the official recall documentation. Users should stop using the affected devices and contact Ventlab Corporation for instructions on return or replacement.
The recalled product
- 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 re
- 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 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
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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