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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 Devicesee related information
Date Initiated by FirmMay 08, 2018
Date PostedAugust 08, 2018
Recall Status1 Terminated 3 on July 07, 2020
Recall NumberZ-2553-2018
Recall Event ID 80500
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
ProductAirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 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 2K8018, Lot Number 0001210201;   b. Part Number 2K8008 Lot Numbers 0001209831, 0001209837;   c. Part Number RE1DK5445D, Lot Numbers 0004002563, 0004003205;   d. Part Number 2K8039, Lot Number 0001209839  
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
ActionVyaire 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 Commerce15,714 units total
DistributionUS 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 CycleTPLC 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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