Device product
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
Z-0724-2021
Product summary
- Event
- Event 86986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 units
- Official record key
device-enforcement:Z-0724-2021
Official wording
Reason: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
Code information: Lot Number: 4178253 Exp. Date: November 2019
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Mislabeled