BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2552-2018 · Initiated May 8, 2018

    Recall

    Recall Number
    Z-2552-2018
    Event Number
    80500
    Firm
    Vyaire Medical
    FEI Number
    2050001
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    May 8, 2018
    Posted
    August 8, 2018
    Terminated
    July 7, 2020
    Address
    26125 N Riverwoods Blvd, Mettawa, IL, 60045-3420

    Description

    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.

    Reason

    An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

    Action

    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: [email protected] Monday-Friday 8:00 am - 5:30 pm CST.

    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.

    Quantity

    15,714 units total