Z-1028-2016 Class II Terminated
FDA device recall Z-1028-2016 was initiated by Cook Inc. on Jan 8, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 134.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2016
- Initiation Date
- Jan 8, 2016
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 134
Product Description
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 for Recall
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.
Distribution Pattern
Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
Code Information
Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1028-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026