Device Recall AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, NonHeated 의 리콜

Recall

61943

Class 1

Z-1900-2012

2012-05-29

2012-06-29

Terminated

United States

2016-01-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109600

The y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. this leak could lead to a decrease in the tidal volume delivered to the ventilated patient.

The firm, CareFusion, sent an "URGENT RECALL NOTICE" dated May 29, 2012 to all of the affected customers on the same date via registered return receipt mail. The notice described the product, problem and actions to be taken. The customers were instructed to immediately destroy any affected product in-stock at their facility and to NOT further distribute these products. NOTE: The notice stated "Carefusion is removing from the the market all lot numbers less than lot #0000414257 or begin with the letter 'Y' for all Infant Breathing Circuit product codes listed in the provided attachment". The customers were also instructed to not return the product to Carefusion. Return the product directly to: Owens and Minor Health Care Logistics at 1651 California Street, Suite C, Redlands, CA 92374, Attn: Recall Coordinator, for immediate replacement. NOTE: The notice the stated "Failure to follow these important measures may result in a potential patient safety risk". In addition, the customers were instructed to forward the recall notice to any customers to whom these products were sold, notifying them of the potential risk, advising them to discard or return any CareFusion AirLife Infant Breathing Circuits with the noted product/lot numbers for replacement; and to complete and return a enclosed reply form indicating the amount of inventory in stock, amount destroyed and amount returned. The distributors were requested to complete and return the attached Acknowledgement Form indicating that they have received the recall notice and that they communicated the Recall Notice to all customers who have purchased the affected breathing circuits via Fax to (847) 473-7774 or email to David.Wehrheim@Carefusion.com. They were also instructed to contact CareFusion Channel Management at (866) 802-6320 for further details on return and/or replacement of stock. If you have any questions related to this information, please call (847) 473-7495 or email David.Wehrheim@Caref