The Recall Desk
HighFDA (Devices)·Z-1899-2012·Announced 2012-07-11

CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter

CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where a mechanical defect could reduce ventilation to a patient, but the source text does not report any specific injuries or illnesses.

Plain-English summary

CareFusion 2200 Inc is recalling AirLife Isothermal Breathing Circuits, Infant Respiratory Circuits, Heated. These prescription devices are used with ventilators to administer mechanical ventilation to patients. The recall covers specific product codes and lot numbers manufactured prior to February 3, 2012, as well as lot #0000414257 and any lot numbers beginning with the letter Y.

The recall was initiated because the Y adapter within the breathing circuit may spontaneously crack. This defect can cause a leak in the closed ventilation system, which could lead to a decrease in the tidal volume delivered to the ventilated patient.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan, and the United Arab Emirates. Healthcare facilities should stop using the affected devices and contact CareFusion for instructions on replacement or return.

The recalled product

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
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Respiratory Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Carefusion 2200 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Carefusion 2200 Inc

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Same hazard · mechanical failure

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