Sophysa S.A. 2024-05-22 Health serious FDA
Health · FDA · Recall #FDA-Z-1826-2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is… Recall
Issued May 22, 2024 · Sophysa S.A.
In May 2024, Sophysa S.A. recalled the The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
What you should do
- 1 Stop using The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sophysa S.A. 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
- Sophysa S.A.
- Category
- Health
- Recall date
- May 22, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, H
- Recall number
- FDA-Z-1826-2024
- Made in
- France
- Issuing agency
- FDA
In context
- Sophysa S.A. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.