FDA Medical Device Recalls (openFDA)
Lemaitre Vascular, Inc.: CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
- Recall number
- Z-0008-2008
- 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)
- Status
- Terminated
- Initiated
- 2007-07-18
- Posted
- 2007-10-04
- Terminated
- 2008-09-08
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K973334"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 1220948
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28