FDA Recall
Terminated
Fluid Administration Set, Custom Kit, REF: K09-02842CP, 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.
Recall: Z-1803-2008
·
Initiated April 8, 2008
Recall
- Recall Number
- Z-1803-2008
- Event Number
- 47880
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- April 8, 2008
- Posted
- September 11, 2008
- Terminated
- April 6, 2009
- Address
- 1600 Merit Pkwy South, Jordan, UT, 84095-2416
Description
Fluid Administration Set, Custom Kit, REF: K09-02842CP, 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.
Reason
Convenience kits may contain non-filtered drip chambers
Action
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.
Distribution
Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
Quantity
95 kits