SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26cm Urological stents are dispo
FDA device recall Z-2220-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FAD
- Quantity affected
- 4
- 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
- Date initiated
- 2008-05-20
- Date posted
- 2008-09-16
- Date terminated
- 2010-04-14
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC URETERAL STENT (K060673) | Applied Medical Resources Corp. | 2006-03-29 |
| MODIFICATION TO URETERAL STENT (K040760) | Applied Medical Resources Corp. | 2004-10-15 |
| C-FLEX URETERAL STENTS (K991219) | Applied Medical Resources | 1999-06-21 |