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Integra LifeSciences Corp. recalls Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shu
Recalled December 30, 2020 · FDA recall Z-0725-2021 · Integra LifeSciences
Hazard
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa · FDA Class II
Units
17 units
Sold at
US Nationwide distribution.
Description
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Product
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →