Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
This recall has been terminated (originally issued June 5, 2007).
- Recall Initiated
- April 11, 2007
- Posted
- June 5, 2007
- Terminated
- December 12, 2007
- Recall Number
- Z-0889-2007
- Quantity
- 15 kits
- Firm Location
- Scientific Place Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
Lot / Code Info
Batch/Lot Numbers: 8529320, 8568190, 9371965
Root Cause
Other
Action Taken
Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
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