Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
FDA Recall Z-2107-2008 · Posted 2008-09-11
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2008-05-14
Date Terminated2010-03-08
Product Quantity15 units
Reason for Recall
Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.
Firm Action
Merit's six sales reps for the six hospital consignees were notified by letter on 05/14/2008. They were instructed to contact the hospitals and have them immediately quarantine any affected product for return to Merit. If you have any questions please contact Jackie Preece, Customer Service at 1-201-253-1600.
Root Cause
Packaging process control
Distribution Pattern
Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.