Vyaire Medical: 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 number

Z-2552-2018

Recalling firm

Vyaire Medical

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.

Status

Terminated

Initiated

2018-05-08

Posted

2018-08-08

Terminated

2020-07-07

Reason

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

Root cause

Equipment maintenance

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: customersupport@Vyaire.com Monday-Friday 8:00 am - 5:30 pm CST.

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.

Lot, serial or model codes

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;

510(k) numbers

not on file

PMA numbers

not on file

Product code

BTM

Firm FEI

2050001

Firm city

Mettawa

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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