Home / Recalls / Medical Devices
Integra LifeSciences Corp. recalls Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged i
Recalled October 12, 2016 · FDA recall Z-2905-2016 · Integra LifeSciences
Hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. · FDA Class II
Units
10
Sold at
Nationwide Distribution to KS only
Description
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Product
Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →