Recall Z-2222-2008 ยท FAD Stent, Ureteral
Applied Medical Resources Corp
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F multilength Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
| Date | Sep 16, 2008 (initiated May 20, 2008) |
| Status | Terminated |
| Reason | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. |
| Root cause | Mixed-up of materials/components |
| Action | On May 20, 2008, Applied Medical began distribution of an Recall Notice with fax-back attachment ( Recall Notification Confirmation Form ) to all customers in the United States via Applied's Direct Sales Force. The Notice informed customers of the problem that caused the initiation of the recall and requested they complete and fax-back the Recall Notification Confirmation Form . The letter also instructed their customers to remove and return affected product to Applied Medical immediately via FedEx. If the customers had an questions they were to contact Mr. Frans VandenBroek at (949) 7l3-8 |
| Quantity | 84 |
| Distribution | Nationwide to: AL, AZ, CA, CO, DC, FL, GA, KY, IL, LA, MI, MN, NC, NJ, NY, PA, TN, TX, WA, WI and Worldwide to: Australia & South Africa |
| FDA record | Open on fda.gov |