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Terminated

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.

FDA Recall Z-2223-2008 · Posted 2008-09-16

Recall StatusTerminated
Product CodeFAD
Date Initiated2008-05-20
Date Terminated2010-04-14
Product Quantity10

Reason for Recall

The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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