Recall Z-0503-2012 ยท KOD Catheter, Urological
Nurse Assist, Inc
REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-758
| Date | Jan 11, 2012 (initiated Sep 2, 2011) |
| Status | Terminated |
| Reason | Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays. |
| Root cause | Component design/selection |
| Action | Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruct |
| Quantity | 4312 CASES |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830359 | STERILE CATHERIZATION PROCEDURE TRAYS Welcon, Inc., Mar 17, 1983 |