FDA Enforcement
Class II
Terminated
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
Recall: Z-0725-2021
·
Reported December 30, 2020
Enforcement
- Recall Number
- Z-0725-2021
- Event ID
- 86986
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2020
- Initiation Date
- December 14, 2020
- Classification Date
- December 23, 2020
- Termination Date
- July 19, 2021
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
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
Reason
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Code Info
Lot Number:4178257 Exp. Date: November 2019
Distribution
US Nationwide distribution.
Quantity
17 units