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U.S. Department of Health and Human Services

Class 2 Device Recall CVI (Cardiovascular Innovations)

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  Class 2 Device Recall CVI (Cardiovascular Innovations) see related information
Date Initiated by Firm July 18, 2007
Date Posted October 04, 2007
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = CARDIOVASCULAR INNOVATIONS
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