Z-2107-2008

Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095...

Name: Z-2107-2008 Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095...
Creator: Merit Medical Systems, Inc.
Published: 2008-05-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2008-05-14 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer... on 2008-05-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2107-2008
Status: Terminated
Initiated: 2008-05-14
Posted: 2008-09-11
Terminated: 2010-03-08
Recalling firm: Merit Medical Systems, Inc.
Product: 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.
Product code: KRA Catheter, Continuous Flush
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 15 units
Distribution: Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.
Product codes and lots: Lot numbers: F496042, and F587928.

Product code KRA

K992231Class IIFOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. / cleared 1999-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)