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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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
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 2		 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.
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