Z-0977-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 units
Product Description
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason for Recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Distribution Pattern
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
Code Information
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.