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
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
foreign matter