Integra LifeSciences Corp. recalls Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged…

Recall date

August 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2905-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Nationwide Distribution to KS only

Why it was recalled

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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