Recall Z-1238-06 ยท FAD Stent, Ureteral
Boston Scientific Corp
Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
| Date | Jul 13, 2006 (initiated May 10, 2006) |
| Status | Terminated |
| Reason | Instructions on how to inject are not included in the package. |
| Root cause | Other |
| Action | A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product. |
| Quantity | 29 |
| Distribution | New York and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010002 | CONTOUR POLARIS URETERAL STENT Boston Scientific Corp, Jan 22, 2001 |