FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent
FDA device recall Z-1985-2010 · posted 2010-08-25 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.
- Action taken
- Boston Scientific sent an "Urgent Medical Device Recall - Immediate Action Required" letter date April 27, 2010 to all consignees. The letter included instructions to immediately discontinue use and segregate the affected product for return, and complete and return by fax a Reply Verification Tracking Form. Customers with affected product were instructed to contact customer service at 866-868-4004 to obtain a Return Authorization (RGA) number, and package and ship the product to Boston Scientific.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 676
- Distribution
- Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Brita
- Date initiated
- 2010-04-27
- Date posted
- 2010-08-25
- Date terminated
- 2011-03-23
- Location
- Quincy, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS (K965147) | Boston Scientific Corp | 1997-06-30 |