ClearanceBrief
Recall Z-0620-03 ยท DQO Catheter, Intravascular, Diagnostic

Merit Medical Systems, Inc

Custom Angiographic Kit.

DateMar 6, 2003 (initiated Feb 13, 2003)
StatusTerminated
ReasonA recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
Root causeOther
ActionConsignees were notified by phone and FAX on 2/12/2003.
Quantity250 kits
DistributionFL and Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K883718MERIT HI-FLEX(TM)
Merit Medical Systems, Inc., Jan 30, 1989
K913682MERIT CUSTOM KIT
Merit Medical Systems, Inc., Nov 15, 1991
K934123STOPCOCK (ONE-PORT MANIFOLD)
Merit Medical Systems, Inc., Nov 23, 1993
K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
Merit Medical Systems, Inc., Nov 25, 1997