FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Inflation Syringe Kit. Catalog Number KOS-02857
- Recall number
- Z-0002-2017
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Inflation Syringe Kit. Catalog Number KOS-02857
- Status
- Terminated
- Initiated
- 2016-08-25
- Posted
- not on file
- Terminated
- 2016-12-01
- Reason
- Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
- Root cause
- Labeling design
- Action
- Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.
- Quantity
- 1,297 total units
- Distribution
- One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
- Lot, serial or model codes
- Lot Numbers: H959038, H970334, H984351.
- 510(k) numbers
- ["K122321"]
- PMA numbers
- not on file
- Product code
- MAV
- 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