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
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
원인
Cook medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle.
potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. there have been no reports of illness or injury associated with this issue.
조치
Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken.
Action to be taken:
1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused.
2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit.
3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical.
4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at fieldactionsna@cookmedical.com.
Transmission of this notice:
This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred.
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.