[Recalled] 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
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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 ventilation is administered |
|---|---|
| Brand / manufacturer | Carefusion 2200 Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1900-2012 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 29 May 2012 |
| EAN / barcode | 0000414257 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from Carefusion 2200 Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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