Recall Z-0889-2007 ยท LJE Catheter, Nephrostomy
Boston Scientific Corporation
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
| Date | Jun 5, 2007 (initiated Apr 11, 2007) |
| Status | Terminated |
| Reason | Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit |
| Root cause | Other |
| Action | Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory. |
| Quantity | 15 kits |
| Distribution | Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.