ClearanceBrief
Recall Z-0512-2010 ยท DXT Injector And Syringe, Angiographic

Merit Medical Systems, Inc.

Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices

DateDec 14, 2009 (initiated Sep 29, 2009)
StatusTerminated
ReasonPotential sterility breach caused by excessive shipment damage.
Root causeOther
ActionMerit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
Quantity5 inflation syringes
DistributionUS (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
Merit Medical Systems, Inc., Apr 18, 1989