Z-2221-2008

SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological...

Name: Z-2221-2008 SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological...
Creator: Applied Medical Resources Corp
Published: 2008-05-20
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2008-05-20 / Terminated

FDA source

Applied Medical Resources Corp began a recall of SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological stents are disposable single-use temporary indwelling... on 2008-05-20. The reason FDA records is "The product is being recalled due to possible movement or dislodgement of the positioner marker band during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2221-2008
Status: Terminated
Initiated: 2008-05-20
Posted: 2008-09-16
Terminated: 2010-04-14
Recalling firm: Applied Medical Resources Corp
Product: SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
Product code: FAD Stent, Ureteral
Reason for recall: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
FDA 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) 7l3-8369 or by e-mail at fvandenbroekappliedmedical.com.
Quantity in commerce: 5
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
Product codes and lots: LOT NUMBER: 1060602

Product code FAD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)