CODMAN CERTAS Plus Valve (Integra) – Incorrect Product Labels (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Products Sold
UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.
Integra LifeSciences Corp. is recalling CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable dev due to Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026