Recall Z-1083-05 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Teleflex Medical
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; Rusch, 2450 Meadowbrook Pwy, Duluth, GA 30096, Assembled in Mexico from U.S. Components; product number RLA-142-3
| Date | Aug 4, 2005 (initiated Jul 11, 2005) |
| Status | Terminated |
| Reason | There is a lack of assurance of sterility for parts of these lots of product. |
| Root cause | Other |
| Action | Teleflex Medical sent their customers recall letters dated July 11, 2005 via UPS, 2 Day Delivery, on July 13, 2005. The customers were informed that there were documentation discrepancies for the two lots which impact the level of assurance that all of the units are sterile, and were instructed to remove and quarantine all affected product immediately and return the product to Teleflex Medical at Research Triangle Park, NC. Any questions were directed to Dan Daily at 1-800-334-9751, ext. 4029. The recall was extended to include the two additional lots by letter dated 11/15/05. The customer |
| Quantity | 95,800 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010420 | RUSCH MMG/O'NEIL CATHETER Rusch, Inc., May 9, 2001 |