Class 3 Device Recall Transend EX

• Date Initiated by Firm: June 14, 2007
• Date Posted: December 05, 2007
• Recall Status: Terminated on December 21, 2007
• Recall Number: Z-0122-2008
• Recall Event ID: 38310
• 510(K)Number: K931584
• Product Classification: Intravascular Catheter Guidewire - Product Code DQX
• Product: Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
• Code Information: Lot Number: 9264947.
• Recalling Firm/ Manufacturer: Boston Scientific Target; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: 508-652-5594
• Manufacturer Reason for Recall: Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
• FDA Determined Cause: Process control
• Action: Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.
• Quantity in Commerce: 40
• Distribution: Nationwide.
• 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.

• 510(K) Database: 510(K)s with Product Code = DQX