Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
Brand
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa
Lot Codes / Batch Numbers
LOT NUMBERS: 1058016, 1059244 and 1060923
Products Sold
LOT NUMBERS: 1058016, 1059244 and 1060923
Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa is recalling SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24cm Urolo due to The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026