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 ventilation is administered to a patient.

Recall Insight

This FDA Devices action (record #Z-1900-2012) was formally reported on July 11, 2012, with the manufacturer initiating the action on May 29, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Carefusion 2200 Inc is listed as the recalling firm, operating out of McGaw Park, IL. Federal records indicate N/A units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.