FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
- Recall number
- Z-2107-2008
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Continuous flush catheter intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
- Status
- Terminated
- Initiated
- 2008-05-14
- Posted
- 2008-09-11
- Terminated
- 2010-03-08
- Reason
- Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter further than intended, posing a potential risk of physical damage to the patient.
- Root cause
- Packaging process control
- Action
- Merit's six sales reps for the six hospital consignees were notified by letter on 05/14/2008. They were instructed to contact the hospitals and have them immediately quarantine any affected product for return to Merit. If you have any questions please contact Jackie Preece, Customer Service at 1-201-253-1600.
- Quantity
- 15 units
- Distribution
- Class II Recall - Nationwide Distribution --- including states of MA, NV, NY, PA, and SC.
- Lot, serial or model codes
- Lot numbers: F496042, and F587928.
- 510(k) numbers
- ["K992231"]
- PMA numbers
- not on file
- Product code
- KRA
- 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