Retiro De Equipo (Recall) de Device Recall Infant AirLife Duallimb

Recall

78636

Class 1

Z-0344-2018

2014-11-29

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160041

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.

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.