FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 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 number
- Z-1803-2008
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-04-08
- Posted
- 2008-09-11
- Terminated
- 2009-04-06
- Reason
- Convenience kits may contain non-filtered drip chambers
- Root cause
- Mixed-up of materials/components
- 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.
- Quantity
- 95 kits
- Distribution
- Class II Recall - Nationwide Distribution --- including states of IL, SC, VA, WI.
- Lot, serial or model codes
- Lot Number F605310
- 510(k) numbers
- ["K915678"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28