FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Fluid Management Set. Catalog Number K08-MP5159A
- Recall number
- Z-0631-2017
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Fluid Management Set. Catalog Number K08-MP5159A
- Status
- Terminated
- Initiated
- 2016-09-23
- Posted
- 2016-11-19
- Terminated
- 2017-03-27
- Reason
- Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
- Root cause
- Process control
- Action
- Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.
- Quantity
- 178 units
- Distribution
- Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
- Lot, serial or model codes
- Lot Number: H996433
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJV
- 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