U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Needle, tumor localization - Product Code MIJ
원인
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.
조치
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.
Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
제품 설명
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.