Integra LifeSciences Corp. recalls Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary pac…

Recall date

August 23, 2016

Source

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

Recall number

Z-2909-2016

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 Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems