FDA Device

Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110

Hazard

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

What You Should Do

Remedy

Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.

Products

Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Brand
Boston Scientific Corporation One Boston
UPC
Batch/Lot Numbers: 8529320, 8568190, 9371965

Units Affected

15 kits