Integra York PA, Inc recalls Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-u…

Recall date

October 28, 2016

Source

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

Recall number

Z-0751-2017

FDA classification

Class II

Brand / firm

Integra York PA, Inc

Sold / distributed

US Distribution in NC and TX.

Why it was recalled

The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.

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

What was recalled

Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.