Z-1028-2016Class II

Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip...

Name: Z-1028-2016 Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip...
Creator: Cook Inc.
Published: 2016-01-08
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-01-08 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire... on 2016-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1028-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-02-29
Terminated: 2017-03-23
Recalling firm: Cook Incorporated
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.
Product code: MIJ Needle, Tumor Localization
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook Medical sent an URGENT: MEDICAL DEVICE RECALL dated January 8, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to do the following: Please review the attached list of affected products and lot numbers shipped to your account, and quarantine any affected product that remains unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Recall Response Form and return to Cook Medical either with the product or separately. 4. Please report any Adverse Event to Cook Medical Customer Relations 1-800- 457-4500 or 1-812-339-2235. Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or email at [email protected] Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
Quantity in commerce: 134
Distribution: Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
Product codes and lots: Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1028-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-02-29

Product code MIJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)