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Class 2 Device Recall Kopans Breast Lesion Localization Needle |
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Date Initiated by Firm |
January 08, 2016 |
Date Posted |
February 29, 2016 |
Recall Status1 |
Terminated 3 on March 23, 2017 |
Recall Number |
Z-1028-2016 |
Recall Event ID |
73083 |
Product Classification |
Needle, tumor localization - Product Code MIJ
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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. |
Code Information |
Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Cook Medical Customer Relations Departme 800-457-4500
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Manufacturer 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.
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FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
134 |
Distribution |
Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA.. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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