—#71411

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.

FDA product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K992231
Affected lot / code info: Lot numbers: F496042, and F587928.

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 Merit Pkwy South, Jordan, Utah 84095

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.

Timeline

Recall initiated: 2008-05-14
Posted by FDA: 2008-09-11
Terminated: 2010-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71411. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.