Sophysa S.A. recalls The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular…
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.…
Read the official notice →- Date
- 2024-05-22
- Country
- United States
- Brand
- Sophysa
- Product
- The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Sophysa recalls
- 2026-01-14
USSophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
FDA · DeviceSophysaUS Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.Official notice →
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- 2024-05-22
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