AirLife Resuscitation Device recall
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask…
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 2K8004, Lot Numbers 0001209844, 0001207350, 0001207351, 0001207352, 0001207353; b. Part Number 2K8035C2, Lot Numbers 0001209833; c. Part Number 2K8017, Lot Numbers 0004003362, 0004003363, 0001209835, 0001209836; d. Part Number 2K8005, Lot Numbers 0001207345, 0001207346, 0001207347, 0001207349, 0001209842, 0001209843; e. Part Number 2K8036, Lot Numbers 0001207354, 0001210191, 0001210192; f. Part Number 2K8001, Lot Numbers 0001209841; g. Part Number 2K8035M, Lot Numbers 001209834; h. Part Number 2K8004C2, Lot Numbers 0001209847;
- Product
- AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask…
- 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)