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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.

FDA Recall Z-2552-2018 · Posted 2018-08-08

Recalling FirmVyaire Medical
Recall StatusTerminated
Product CodeBTM
Date Initiated2018-05-08
Date Terminated2020-07-07
Product Quantity15,714 units total

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.

Firm 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.

Root Cause

Equipment maintenance

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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