Recall Z-0008-2008 ยท DXT Injector And Syringe, Angiographic
Lemaitre Vascular, Inc.
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
| Date | Oct 4, 2007 (initiated Jul 18, 2007) |
| Status | Terminated |
| Reason | Sterility of device may be compromised due to breach in sterile barrier. |
| 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 | 7,860 units |
| Distribution | Worldwide, including USA, Canada, Netherlands, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973334 | OZ POWER SYRINGE Cardiovascular Innovations, Apr 3, 1998 |