Cook product recalled over foreign material

Recall date

January 8, 2016

Source

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

Official notice title

Cook Inc. recalls Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle wi…

Recall number

Z-1028-2016

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..

Why it was recalled

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.

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

What was recalled

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.