VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
FDA device recall Z-0242-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences AG
- Reason for recall
- Seal integrity, sterility not assured.
- Action taken
- Letter was sent to all customers requesting return of the unused lot on 11/20/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 21150
- Distribution
- Nationwide.
- Date initiated
- 2003-11-20
- Date posted
- 2003-12-18
- Date terminated
- 2004-11-30
- Location
- San Cristobal, Dominican Republic
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