| Class 1 Device Recall Vyaire AirLife | |
Date Initiated by Firm | January 10, 2024 |
Date Posted | February 25, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1058-2024 |
Recall Event ID |
93821 |
Product Classification |
Ventilator, emergency, manual (resuscitator) - Product Code BTM
|
Product | AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001 |
Code Information |
UDI/DI Case: 50190752114096, Each: 10190752114098; 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 | 66,078 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 |
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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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