Integra LifeSciences Corp.: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of C

Hazard

Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

Details from the source

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. Quantity: 170 units Lot/code info: UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.

UPC codes

10381780535881

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.