Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN
FDA device recall Z-1238-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Instructions on how to inject are not included in the package.
- Action taken
- A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FAD
- Quantity affected
- 29
- Distribution
- New York and Pennsylvania.
- Date initiated
- 2006-05-10
- Date posted
- 2006-07-13
- Date terminated
- 2006-11-01
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONTOUR POLARIS URETERAL STENT (K010002) | Boston Scientific Corp | 2001-01-22 |