FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA
- Recall number
- Z-0559-2011
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
- Status
- Terminated
- Initiated
- 2010-10-25
- Posted
- 2010-12-08
- Terminated
- 2012-03-23
- Reason
- Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
- Root cause
- Process control
- Action
- Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.
- Quantity
- 57 units
- Distribution
- Nationwide Distribution in the states of CA, IL, IN, and UT.
- Lot, serial or model codes
- Lot No.: H158143
- 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
- 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