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Terminated

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

FDA Recall Z-0889-2007 · Posted 2007-06-05

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJE
Date Initiated2007-04-11
Date Terminated2007-12-12
Product Quantity15 kits

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

Firm Action

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

Distribution Pattern

Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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