CLASS I Device recall · Reported 11 Jul 2012 · FDA Enforcement Report

AirLife Isothermal Breathing Circuit Accessory recalled

Carefusion 2200 is recalling AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector, distributed nationwide in the US. The recall was initiated on 29 May 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesproduct 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.

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1901-2012
FDA event ID: 61943
Recalling firm: Carefusion 2200, McGaw Park, IL
Classification: Class I
Status: Terminated
Recall initiated: 29 May 2012
FDA classified: 29 Jun 2012
Reported: 11 Jul 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: CPAP & Ventilators

Timeline

29 May 2012	Recall initiated by company
29 Jun 2012	Classified by FDA	+31 days
11 Jul 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector recalled?

Yes. Carefusion 2200 recalled AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector on 29 May 2012. The recall is Class I and its status is Terminated. Recall number Z-1901-2012.

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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