Class 2 Device Recall

• Date Initiated by Firm: March 18, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 25, 2005
• Recall Number: Z-0842-04
• Recall Event ID: 28669
• Product Classification: Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
• Product: Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.
• Code Information: 929123, Exp. 12/2006
• FEI Number: 3017892510
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: Robert E. Franklin; 518-742-4411
• Manufacturer Reason for Recall: Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
• FDA Determined Cause: Other
• Action: Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.
• Quantity in Commerce: 43 units
• Distribution: Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.
• Total Product Life Cycle: TPLC 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.