FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
- Recall number
- Z-1320-2014
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
- Status
- Terminated
- Initiated
- 2014-03-13
- Posted
- 2014-04-03
- Terminated
- 2014-07-07
- Reason
- The products are labeled as sterile but were not sterilized.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.
- Quantity
- 15
- Distribution
- Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
- Lot, serial or model codes
- Lot Number H574228
- 510(k) numbers
- ["K875196"]
- PMA numbers
- not on file
- Product code
- FMF
- 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