FDAFDA · Food and drugs·Recall number Z-1028-2016
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.
Published March 9, 2016 · Recall initiated: January 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
- Lot
- Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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