Z-1899-2012Class I

AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient...

Name: Z-1899-2012 AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient...
Creator: Carefusion 2200 Inc
Published: 2012-05-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-05-29 / Terminated / root cause: manufacturing process

FDA source

Carefusion 2200 Inc began a recall of AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba... on 2012-05-29. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1899-2012
Classification: Class I
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-06-29
Terminated: 2016-01-22
Recalling firm: Medtronic, Inc.
Product: AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; 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.
Product code: BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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
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.
Product codes and lots: product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1899-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1899-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1900-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29
Z-1901-2012	Class I	Terminated	Voluntary: Firm initiated	2012-07-11	2012-06-29

Product code BZE

K915226Class IIIsothermal Heated Ventilator & Anesthesia CircuitBaxter Healthcare Corp / cleared 1993-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)