Z-0008-2008

CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035...

Name: Z-0008-2008 CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035...
Creator: Lemaitre Vascular, Inc.
Published: 2007-07-18
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2007-07-18 / Terminated / root cause: packaging

FDA source

Lemaitre Vascular, Inc. began a recall of CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) on 2007-07-18. The reason FDA records is "Sterility of device may be compromised due to breach in sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0008-2008
Status: Terminated
Initiated: 2007-07-18
Posted: 2007-10-04
Terminated: 2008-09-08
Recalling firm: LeMaitre Vascular Inc.
Product: CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Sterility of device may be compromised due to breach in sterile barrier.
Root cause tag: packaging
FDA root 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.
Product codes and lots: 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.

Product code DXT

K973334Class IIOz Power SyringeCardiovascular Innovations / cleared 1998-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)