[Recalled] Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requ |
|---|---|
| Brand / manufacturer | Vyaire Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0343-2018 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 29 November 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of 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 →
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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.