Fresenius Medical Care Holdings, Inc. 2024-05-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1822-2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for… Recall
Issued May 22, 2024 · Fresenius Medical Care Holdings, Inc.
In May 2024, Fresenius Medical Care Holdings, Inc. recalled the Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
What you should do
- 1 Stop using Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Medical Care Holdings, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Medical Care Holdings, Inc.
- Category
- Health
- Recall date
- May 22, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-1822-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Medical Care Holdings, Inc. has 8 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.