Lemaitre Vascular, Inc. CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Brand
Lemaitre Vascular, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Lemaitre Vascular, Inc. is recalling CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref due to Sterility of device may be compromised due to breach in sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility of device may be compromised due to breach in sterile barrier.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026