The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1901-2012·Announced 2012-07-11

CareFusion Infant Y Connector Recall Due to Spontaneous Cracking

CareFusion is recalling AirLife Infant Patient Y Connectors because the adapter may crack, causing a leak that reduces the air volume delivered 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 classification is FDA Class I, which mandates a minimum score of 4 per the rubric. Additionally, the defect involves a structural failure in a life-support device that can directly compromise patient ventilation.

Plain-English summary

CareFusion 2200 Inc is recalling the AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector. This is a prescription medical device used with ventilators for single-patient use. The recall includes product codes 5925-504 and 6603-504, specifically all lot numbers manufactured prior to February 3, 2012, lot #0000414257, and any lot numbers beginning with the letter Y.

The recall is being issued 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 and users should stop using the affected connectors and contact CareFusion for further instructions.

The recalled product

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…
Manufacturer
Carefusion 2200 Inc
Category
Medical Device — Respiratory / Ventilator Accessories
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 (3)

  • product codes 5925-504 and 6603-504
  • 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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