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
Introducer, catheter - Product Code DYB
원인
Incorrect packaging. reports of packages labeled as 6.0fr actually containing 5.0fr devices.
조치
On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration 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.
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.
Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY.
제품 설명
Flexor Check-Flo Introducer, Catheter introducer, || Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC || Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices