Class 2 Device Recall

• Date Initiated by Firm: October 21, 2004
• Date Posted: December 09, 2004
• Recall Status: Terminated on October 13, 2005
• Recall Number: Z-0302-05
• Recall Event ID: 30489
• Product Classification: Needle, Hypodermic, Single Lumen - Product Code FMI
• Product: NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
• Code Information: Lot #990024
• FEI Number: 3017892510
• Recalling Firm/ Manufacturer: Boston Scientific Corp; 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: John Watkins; 518-742-4411
• Manufacturer Reason for Recall: The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
• FDA Determined Cause: Other
• Action: Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.
• Quantity in Commerce: 128 kits
• Distribution: 2 customers in IL and NV.
• 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.