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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientiific PCNL

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 Class 2 Device Recall Boston Scientiific PCNLsee related information
Date Initiated by FirmApril 11, 2007
Date PostedJune 05, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall NumberZ-0889-2007
Recall Event ID 37886
Product Classification Percutaneous Tract Kit - Product Code LJE
ProductBoston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Code Information Batch/Lot Numbers: 8529320, 8568190, 9371965
FEI Number 3001451463
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
Manufacturer 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
FDA Determined
Cause 2		Other
ActionBoston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
Quantity in Commerce15 kits
DistributionWorldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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