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U.S. Department of Health and Human Services

Class 1 Device Recall AirLife Resuscitation Device

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  Class 1 Device Recall AirLife Resuscitation Device see related information
Date Initiated by Firm May 08, 2018
Date Posted August 08, 2018
Recall Status1 Terminated 3 on July 07, 2020
Recall Number Z-2552-2018
Recall Event ID 80500
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
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.

Code Information 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;
Recalling Firm/
Manufacturer
Vyaire Medical
26125 N Riverwoods Blvd
Mettawa IL 60045-3420
For Additional Information Contact
833-327-3284
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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