AirLife Adult Manual Resuscitator recall: Mold
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Why was AirLife Adult Manual Resuscitator recalled?
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI Case: 50190752114133, Each: 10190752114135; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
- Product
- AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
- Recalling firm
- Vyaire Medical
- Quantity
- 8,220 units
- Distribution
- Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)