ClearanceBrief
Recall Z-0912-03 ยท FMF Syringe, Piston

Merit Medical Systems, Inc

Inject 10 Coronary Control Syringe (CCS), 10ml

DateJun 5, 2003 (initiated May 16, 2003)
StatusTerminated
ReasonCracks in the syringe barrels could allow for air aspiration into the syringe barrel.
Root causeOther
ActionOn 5/16/2003, all distributors and consignees were notified by letter.
Quantity7257 units
DistributionNationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CC
Merit Medical Systems, Inc., Feb 11, 1988