Recalls / —
—#70413
Product
Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contrast media and saline from a container to a patient's vascular system.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K915678
- Affected lot / code info
- Lot Number F604048
Why it was recalled
Convenience kits may contain non-filtered drip chambers
Root cause (FDA determination)
Mixed-up of materials/components
Action the firm took
An Urgent Product Recall Notice was issued on 04/08/2008 requiring that all affected product be returned to Merit. A response form was included with the notification letter.
Recalling firm
- Firm
- Merit Medical Systems, Inc.
- Address
- 1600 Merit Pkwy South, Jordan, Utah 84095-2416
Distribution
- Distribution pattern
- Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
Timeline
- Recall initiated
- 2008-04-08
- Posted by FDA
- 2008-09-11
- Terminated
- 2009-04-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70413. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.