FDA Medical Device Recalls (openFDA)
Edwards Lifesciences AG: VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
- Recall number
- Z-0242-04
- Recalling firm
- Edwards Lifesciences AG
- Product
- VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
- Status
- Terminated
- Initiated
- 2003-11-20
- Posted
- 2003-12-18
- Terminated
- 2004-11-30
- Reason
- Seal integrity, sterility not assured.
- Root cause
- Other
- Action
- Letter was sent to all customers requesting return of the unused lot on 11/20/2003.
- Quantity
- 21150
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 58151473
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3003081151
- Firm city
- San Cristobal
- Firm state
- not on file
- Firm country
- Dominican Republic
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