The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1900-2012·Announced 2012-07-11

CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter

CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."

Plain-English summary

CareFusion 2200 Inc is recalling AirLife Isothermal Breathing Circuits, Infant Respiratory Circuit, Non-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 is due to a defect where the Y adapter within the breathing circuit may spontaneously crack. This cracking 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 return or replacement.

The recalled product

Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-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…
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Respiratory
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 (17)

  • product codes 0260-503
  • 0778-503
  • 10392-503
  • 10416-503
  • 10448-507
  • 10734-503
  • 10852-503
  • 1209-503
  • 1535-503
  • 1853-503
  • 5599-503
  • 5643-503
  • 5898-503
  • 6189-503
  • 6800-503 and RC41-00097
  • 2012
  • lot #0000414257 and any lot numbers beginning with the letter Y.

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 →

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