Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous
FDA device recall Z-2107-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 15 units
- Distribution
- Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.
- Date initiated
- 2008-05-14
- Date posted
- 2008-09-11
- Date terminated
- 2010-03-08
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FOUNTAIN Infusion Catheter and Occluding Guide Wire (K992231) | Merit Medical Systems, Inc. | 1999-07-23 |