Recall record at a glance
| Official record | Z-1385-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Completed |
| Recalling firm | Hamilton Medical AG |
| Report date | Jul 20, 2022 |
| Recall initiation date | Jan 5, 2021 |
| Quantity | 203 |
| Location | Bonaduz, Switzerland |
Official product description
HAMILTON-H900 Humidifier, Models: 950001, 950004
Why the product was recalled
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Distribution information
US: WI, FL, CA, NV, PA, TX, PA
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.