Integra LifeSciences Corp. recalls Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek po…

Recall date

August 23, 2016

Source

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

Recall number

Z-2908-2016

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 Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF