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Recall Observatory FDA recall evidence

Device 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.

Z-1028-2016

January 08, 2016

Class II

Product summary

Firm
Cook Inc.
Event
Event 73083
Status
Terminated
Classification
Class II
Quantity
134
Official record key
device-enforcement:Z-1028-2016

Official wording

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.

Code information: Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign matter