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U.S. Department of Health and Human Services

Class 1 Device Recall Vyaire AirLife

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  Class 1 Device Recall Vyaire AirLife see related information
Date Initiated by Firm January 10, 2024
Date Posted February 25, 2024
Recall Status1 Open3, Classified
Recall Number Z-1059-2024
Recall Event ID 93821
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
Product AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Code Information UDI/DI Case: 50190752114133, Each: 10190752114135; All manufacturing dates of 2017 and prior, and any products without a manufacturing date.
Recalling Firm/
Manufacturer		 Vyaire Medical
26125 N Riverwoods Blvd
Mettawa IL 60045-3420
For Additional Information Contact Rob Yamashita
616-259-8400
Manufacturer Reason
for Recall		 Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
FDA Determined
Cause 2		 Process control
Action Vyaire issued an URGENT: Customer notification Letter to its consignees on 01/10/2024 via letter delivered by UPS Next Day Air. The notice explained the problem, complaints received, and requested the consignee discard or destroy all affected devices. If the consignee further distributed the product, they were directed to forward a copy of the notice to those parties.
Quantity in Commerce 8,220 units
Distribution Worldwide distribution. US nationwide, Brazil, Canada, Switzerland, France, UK, Mexico, Netherlands, Saudi Arabia, Sweden, and South Africa
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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