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Vyaire Medical recalls AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Numbe
Recalled August 15, 2018 · FDA recall Z-2552-2018 · Vyaire Medical
Hazard
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use. · FDA Class I
Units
15,714 units total
Sold at
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.
Description
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Product
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
Manufacturer(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →