Boston Scientific Corporation Recall 86880
Description: Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Boston Scientific Corporation Recall 86880 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0758-2021 |
| Event ID | 86880 |
| Event Description | Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190 |
| Product Type | Devices |
| Distribution | Distribution US nationwide and Japan. |
| Quantity | 458 units |
| Recall Reason | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. |
| Device Classification | 20210106 |
| Device Code Info | GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020. |
| Center Classification Date | 20201230 |
| Recall Initiation Date | 20201116 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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