Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
FDA device recall Z-0889-2007 · posted 2007-06-05 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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
- Action taken
- Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJE
- Quantity affected
- 15 kits
- Distribution
- Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
- Date initiated
- 2007-04-11
- Date posted
- 2007-06-05
- Date terminated
- 2007-12-12
- Location
- Natick, MA
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