FDA-Device2020-12-30Class II
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
Integra LifeSciences Corp.
Hazard
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Sold states
US Nationwide distribution.
Affected count
85 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0724-2021Don't want to check this manually?
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