PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING

Basic information on record for this barcode. Check its recall status and where to find it below.

Barcode (EAN/GTIN)3760124132922
BrandSOPHYSA
CategoryMedical Device
GS1 registrantGS1 France (France)

Safety check

🟡 Open recall on file · 2024-04-09 · France
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.
Source: US FDA - Medical Devices · last fetched 2026-05-31 · Verify on US FDA →

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