FDAAugust 23, 2016device

CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek pouch, Five (5) sealed pouches are packaged in a cardboard box. For use with CUSA DISSECTRON Hand pieces and Sontrodes

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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