Z-0751-2017 Class II Terminated

Recalled by Integra York PA, Inc — York, PA

Recall Details

Product Type
Devices
Report Date
December 21, 2016
Initiation Date
October 28, 2016
Termination Date
April 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
150 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Distribution in NC and TX.

Code Information

Catalog # ST7-138; lot# 352