Recall Z-2223-2008
Applied Medical Resources Corp · initiated May 20, 2008
Product
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F multilength Urological stents are disposable sing-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
Codes / lots: LOT NUMBERS: 1060921 and 1062602
Reason for recall
The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
FDA-determined cause: Mixed-up of materials/components
Action taken
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) 7l3-8369 or by e-mail at fvandenbroekappliedmedical.com.
Details
- Recall number
- Z-2223-2008
- Initiated
- May 20, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- April 14, 2010
- Product code
- FAD – Stent, Ureteral
- Quantity
- 10
- 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
- Recalling firm
- Applied Medical Resources Corp, Rancho Santa Margarita, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2219-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | 05/20/2008Terminated |
| Z-2220-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | 05/20/2008Terminated |
| Z-2221-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | 05/20/2008Terminated |
| Z-2222-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | 05/20/2008Terminated |
| Z-2224-2008 | SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x…The product is being recalled due to possible movement or dislodgement of the positioner marker band during… | 05/20/2008Terminated |