Class 2 Device Recall CVI (Cardiovascular Innovations)

• Date Initiated by Firm: July 18, 2007
• Date Posted: October 04, 2007
• Recall Status: Terminated on September 08, 2008
• Recall Number: Z-0008-2008
• Recall Event ID: 38894
• 510(K)Number: K973334
• Product Classification: contrast media injector - Product Code DXT
• Product: CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
• Code Information: Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
• Recalling Firm/ Manufacturer: Lemaitre Vascular, Inc.; 63 Second Avenue; Burlington MA 01803-4413
• For Additional Information Contact: Roli Kumar; 781-221-2266
• Manufacturer Reason for Recall: Sterility of device may be compromised due to breach in sterile barrier.
• FDA Determined Cause: Package design/selection
• Action: The firm issued a "Adivsory Notice" to accounts 7/18/07, advising them to examine inventory and remove product with defective packaging. The firm issued an updated notification dated 9/24/07 advising users to return recalled lots instead of conducting an examination of the product at the user site.
• Quantity in Commerce: 7,860 units
• Distribution: Worldwide, including USA, Canada, Netherlands, and Germany.
• 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 = DXT