CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovasc
FDA device recall Z-0008-2008 · posted 2007-10-04 · Terminated
Recall details
- Recalling firm
- Lemaitre Vascular, Inc.
- Reason for recall
- Sterility of device may be compromised due to breach in sterile barrier.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 7,860 units
- Distribution
- Worldwide, including USA, Canada, Netherlands, and Germany.
- Date initiated
- 2007-07-18
- Date posted
- 2007-10-04
- Date terminated
- 2008-09-08
- Location
- Burlington, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OZ POWER SYRINGE (K973334) | Cardiovascular Innovations | 1998-04-03 |