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U.S. Department of Health and Human Services

Class 2 Device Recall SILHOUETTE XTRAFLO DEVICE

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  Class 2 Device Recall SILHOUETTE XTRAFLO DEVICE see related information
Date Initiated by Firm May 20, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on April 14, 2010
Recall Number Z-2223-2008
Recall Event ID 48688
510(K)Number K991219  K040760  K060673  
Product Classification Stent Positioner - Product Code FAD
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.
Code Information LOT NUMBERS: 1060921 and 1062602
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Frans VandenDroek
949-713-8369
Manufacturer Reason
for Recall		 The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
FDA Determined
Cause 2		 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 fvandenbroek¿¿appliedmedical.com.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FAD and Original Applicant = APPLIED MEDICAL RESOURCES
510(K)s with Product Code = FAD and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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