Carefusion 2200 Inc: AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Recall number

Z-1901-2012

Recalling firm

Carefusion 2200 Inc

Product

AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.

Status

Terminated

Initiated

2012-05-29

Posted

2012-06-29

Terminated

2016-01-22

Reason

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.

Root cause

Equipment maintenance

Action

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

Quantity

not on file

Distribution

Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.

Lot, serial or model codes

product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.

510(k) numbers

["K915226"]

PMA numbers

not on file

Product code

BZE

Firm FEI

3008002452

Firm city

McGaw Park

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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