Recall record at a glance
| Official record | Z-2706-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Vapotherm, Inc. |
| Report date | Oct 1, 2014 |
| Recall initiation date | Aug 13, 2014 |
| Quantity | 207 units |
| Location | Exeter, NH, United States |
Official product description
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system
Why the product was recalled
Water may leak into the center gas lumen of the Patient Circuit
Distribution information
Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA 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
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