FDA-Device2016-10-12Class II
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
Integra LifeSciences Corp.
Hazard
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Sold states
Nationwide Distribution to KS only
Affected count
10
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2905-2016Don't want to check this manually?
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