Class 2 Device Recall CystoCare Coloplast

• Date Initiated by Firm: January 20, 2011
• Date Posted: May 25, 2011
• Recall Status: Terminated on October 25, 2012
• Recall Number: Z-2287-2011
• Recall Event ID: 58021
• Product Classification: Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
• Product: Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark Tray Label: Cysto-Care Coloplast REF: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 14 Fr. PVC Nelaton catheter Swabsticks (3) PVP solution For Rx only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are urological catheter trays.
• Code Information: Lot Codes:1002198, 1006070, 1007367, 1010126, 806278, 809071, 1001327, 1002033, 1002196, 1002265, 1003052, 1003279, 1003331, 1003343, 1004241, 1004328, 1005004, 1005180, 1005321, 1006318, 1007025, 1008022, 1008198, 806075, 806124, 806208, 806279, 902051, 902314, 904044, 904353, 905183, 905305, 906033, 906037, 906224, 907176, 907227, 908149, 908346, 909174, 909269, 910220, and 910407.
• Recalling Firm/ Manufacturer: Nurse Assist, Inc; 3400 Northern Cross Blvd; Fort Worth TX 76137-3600
• For Additional Information Contact: 817-231-1300 Ext. 14
• Manufacturer Reason for Recall: The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 3,928 cases
• Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

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.