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
Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
원인
The irrigation procedure trays contain triad group alcohol prep pads recalled by triad group because they have the potential to be contaminated with an objectionable organism.
조치
The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137.
Only the product and lots identified on the attached list are affected.
If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
제품 설명
Case Label: REORDER NO. 6102 STERILE WELCON BRAND Standard Irrigation Tray Thumb Control Ring Piston Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Product Label: REORDER NO. 6102 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6000, R1 WELCON BRAND Standard Irrigation Tray With Piston Syringe SINGLE USE 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad 500 mL Graduate 1200 mL Graduated Tray 60cc Thumb Ring Piston Syringe Tip Protector Alcohol Wipe || Intended use: The trays are irrigation trays for catheters