—#143030

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.

FDA product code: MIJ — Needle, Tumor Localization
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 FieldActionsNA@Cookmedical.com 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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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

Timeline

Recall initiated: 2016-01-08
Posted by FDA: 2016-02-29
Terminated: 2017-03-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143030. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.