Recall Z-1028-2016— Cook Inc.

Class II FDA medical device recall by Cook Inc., initiated 2016-01-08, terminated 2017-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.. Reason: Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids..

Recalling firm

Cook Inc.

Classification

Class II

Status

Terminated

Initiated

2016-01-08

Terminated

2017-03-23

Firm location

Bloomington, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.