FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Recall number
- Z-0843-2007
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Status
- Terminated
- Initiated
- 2007-04-17
- Posted
- 2007-05-31
- Terminated
- 2008-05-05
- Reason
- Male luer in fluid administration sets may crack due to inadequate molding process
- Root cause
- Other
- Action
- Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
- Quantity
- 117 units
- Distribution
- CA, IL, NJ, NY. No military, government or foreign distribution.
- Lot, serial or model codes
- Lot Number F524277
- 510(k) numbers
- ["K915678"]
- PMA numbers
- not on file
- Product code
- FMG
- 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