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U.S. Department of Health and Human Services

Class 1 Device Recall Infant AirLife Duallimb

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  Class 1 Device Recall Infant AirLife Duallimb see related information
Date Initiated by Firm November 29, 2014
Create Date January 24, 2018
Recall Status1 Completed
Recall Number Z-0344-2018
Recall Event ID 78636
510(K)Number K160764  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290.

The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Code Information 0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759
Recalling Firm/
Manufacturer
Vyaire Medical
75 N Fairway Dr
Vernon Hills IL 60061-1845
Manufacturer Reason
for Recall
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated November 29th, 2017 to its customers. The recall letter described the product, problem and actions to be taken. The customers were instructed to do the following: "ALL CUSTOMERS: ~ Inspect current inventory on-hand. A 100% physical inventory should immediately be performed to identify and remove affected lots of the AirLife Humidification Chamber(s) and Heated Breathing Circuit Kit(s) due to the identified potential patient safety risk. ~ Destroy all affected product(s) in-stock in accordance with your facility's destruction protocol. ~ If you are a healthcare facility or distributor that has further distributed affected product you must further notify your customers of this URGENT RECALL NOTIFICATION. CUSTOMERS THAT HAVE PURCHASED DIRECT FROM VYAIRE: ~ Complete the Customer Response Form (Appendix 2) and return to GMB-GLBALFieldActions@CareFusion.com ~ If you wish to receive credit of your in-stock product affected by this recall or to place an order for the replacement Model/Part Numbers (as referenced per #6. Per the FAQ's) please contact Vyaire Medical's Customer Service Department at 800.323.9088 (Option #1, followed by Option #1) Monday-Friday 8:00 am CST - 5:00 pm CST. *Please have your original PO number available when calling to expedite the credit process. CUSTOMERS THAT HAVE PURCHASED THROUGH A DISTRIBUTOR: ~ Please work with your distributor to receive credit of your in-stock product affected by this recall. For any additional questions and support concerning this voluntary recall, please contact Clinical Risk Coordinator, at 827-757-0109 or lindy.schenning@vyaire.com.
Quantity in Commerce 16,670 units in total
Distribution US Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = BTT and Original Applicant = CAREFUSION 2200, INC.
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