Z-0724-2021 Class II Terminated
FDA device recall Z-0724-2021 was initiated by Integra LifeSciences Corp. on December 14, 2020 and is designated Class II. Reason for recall: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa The recall status is terminated (terminated July 19, 2021). Affected quantity: 85 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2020
- Initiation Date
- December 14, 2020
- Termination Date
- July 19, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
Product Description
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
Reason for Recall
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: 4178253 Exp. Date: November 2019