ClearanceBrief
Recall Z-0242-04 ยท KRA Catheter, Continuous Flush

Edwards Lifesciences AG

VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.

DateDec 18, 2003 (initiated Nov 20, 2003)
StatusTerminated
ReasonSeal integrity, sterility not assured.
Root causeOther
ActionLetter was sent to all customers requesting return of the unused lot on 11/20/2003.
Quantity21150
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.