Sophysa S.A.: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution in the states of AZ, NY, TX and the countries of ARGENTINA, CHINA, CZECH REPUBLIC, FRANCE, GREECE, HUNGARY, JAPAN, PAKISTAN, Portugal, ROMANIA, SOUTH AFRICA, SWEDEN, VIETNAM. Quantity: 3487 units OUS Lot/code info: UDI-DI: 03760124131482 OUS Serial Numbers: 22C02558 22C02582 22C07751 22C07753 22C09753 22C09757 22C09772 22C09780 22C09781 22C09783 22C09850 22C11644 22C13089 22C14035 22C14036 22C14151 22C14152 22C14153 22C14154 22C14156 22C14158 22C14159 22C14165 22C14166 22C14167 22C14171 22C14172 22C14173 22C14174 22C14178 23C02554 23C03278 23C03279 23C03280 23C03281 23C03282 23C03283 23C03284 23C03285 23C03286 23C03287 23C03288 23C03289 23C03290 23C03291 23C03295 23C03302 23C03308 23C03310 23C03314 23C03315 23C03316 23C03317 23C07704 23C07710 23C07718 23C60201 23C60202 23C60203 23C60209 23C60210 23C60211 23C60212 23C60227 23C60232 23C60233 23C60240 23C60270 23C60271 23C60273 23C60275 23C60276 23C60277 23C60278 23C60282 23C60283 23C60284 22C22761 22C33393 22C33394 22C33395 22C33396 22C33397 22C33398 22C33642 22C41544 22C41545 22C41546 22C41547 22C41548 22C41553 22C41554 22C41557 22C41558 22C41560 22C41810 22C41811 22C41812 22C41813 22C41814 22C41815 22C41817 22C41818 22C41820 22C41821 22C41822 22C41824 22C42031 22C42032 22C42033 22C42034 22C42038 22C42040 22C42041 22C57405 22C57408 22C57409 22C57411 22C57412 22C57413 22C58468 22C58469 22C58470 22C58471 22C58472 22C58473 22C58474 22C58477 22C00882 22C00883 22C01603 22C01604 22C01605 22C01606 22C01607 22C02085 22C04231 22C05404 22C05407 22C05492 22C05494 22C05598 22C05599 22C05600 22C59630 22C59631 22C01874 22C05601 22C04267 22C05603 22C59632 22C05403 22C05602 22C05604 22C05405 22C05400 22C59633 22C02888 22C02891 22C03378 22C03380 22C03381

UPC codes

03760124131482

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.