AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8
FDA device recall Z-2552-2018 · posted 2018-08-08 · Terminated
Recall details
- Recalling firm
- Vyaire Medical
- Reason for recall
- An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
- Action taken
- Vyaire Medical notified customers on about 05/08/2018 via URGENT RECALL NOTIFICATION letter. Instructions included to conduct 100% physical inventory for any affected devices, destroy any affected devices according to each facility's destruction protocol, notify customers of the recall if affected devices have been further distributed, and complete and return the Customer Response Form. Questions and comments can be directed to Vyaire Medical's Customer Support Team at 1-833-327-3284 (Option #1) or email: customersupport@Vyaire.com Monday-Friday 8:00 am - 5:30 pm CST.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 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.
- Date initiated
- 2018-05-08
- Date posted
- 2018-08-08
- Date terminated
- 2020-07-07
- Location
- Mettawa, IL
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