SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured ureters.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- May 20, 2008
- Posted
- September 16, 2008
- Terminated
- April 14, 2010
- Recall Number
- Z-2220-2008
- Quantity
- 4
- Firm Location
- Margarita, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
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
Lot / Code Info
LOT NUMBER: 1059245
Root 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.