FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Merit Custom Procedure Kit
- Recall number
- Z-0078-06
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Merit Custom Procedure Kit
- Status
- Terminated
- Initiated
- 2005-09-02
- Posted
- 2005-10-21
- Terminated
- 2005-10-28
- Reason
- Component of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
- Root cause
- Other
- Action
- Consignees were notified by letter on 9/2/2005.
- Quantity
- 84 units
- Distribution
- DC, MD, VA. Foreign distributiion to Netherlands and Switzerland. No government or military accounts.
- Lot, serial or model codes
- Part Number: K09-08347, Lot Numbers: A304591, A322679.
- 510(k) numbers
- ["K913682"]
- PMA numbers
- not on file
- Product code
- DQO
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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