AirLife Resuscitation Device recall
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number…
Why was AirLife Resuscitation Device recalled?
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
a. Part Number 2K8018, Lot Number 0001210201; b. Part Number 2K8008 Lot Numbers 0001209831, 0001209837; c. Part Number RE1DK5445D, Lot Numbers 0004002563, 0004003205; d. Part Number 2K8039, Lot Number 0001209839
- Product
- AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number…
- Recalling firm
- Vyaire Medical
- Quantity
- 15,714 units total
- Distribution
- US distribution only to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.
- Recall date
- August 15, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)