Z-0242-04

VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood

Name: Z-0242-04 VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood
Creator: Edwards Lifesciences AG
Published: 2003-11-20
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2003-11-20 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences AG began a recall of VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood on 2003-11-20. The reason FDA records is "Seal integrity, sterility not assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0242-04
Status: Terminated
Initiated: 2003-11-20
Posted: 2003-12-18
Terminated: 2004-11-30
Recalling firm: Edwards Lifesciences LLC
Product: VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Seal integrity, sterility not assured.
Root cause tag: packaging
FDA root cause: Other
Action: Letter was sent to all customers requesting return of the unused lot on 11/20/2003.
Quantity in commerce: 21150
Distribution: Nationwide.
Product codes and lots: Lot 58151473

Product code KRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)