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.
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- December 16, 2024
- Posted
- January 17, 2025
- Recall Number
- Z-0977-2025
- Quantity
- 132 units
- Firm Location
- Princeton, NJ
Reason for Recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Distribution
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.
Lot / Code Info
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Root Cause
Labeling Change Control
Action Taken
Integra LifeSciences notified consignees on about 12/16/2024 via letter. Consignees were instructed to review and understand the information provided in the letter, complete and return the provided Customer Acknowledgement Form, remove any affected units from service and quarantine them, arrange for return of affected units, and forward the notification to anyone who utilizes the affected units. Distributors were instructed to follow the same directions but also requested to notify any customers if product was further distributed, and return affected units.