Recall Z-2107-2008 ยท KRA Catheter, Continuous Flush
Merit Medical Systems, Inc.
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.
| Date | Sep 11, 2008 (initiated May 14, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 15 units |
| Distribution | Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992231 | FOUNTAIN Infusion Catheter and Occluding Guide Wire Merit Medical Systems, Inc., Jul 23, 1999 |