FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Recall number
- Z-1700-2008
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.
- Status
- Terminated
- Initiated
- 2008-04-15
- Posted
- 2008-09-04
- Terminated
- 2008-09-03
- Reason
- Convenience kits may be non-sterile due to inadequate package sealing.
- Root cause
- Process control
- Action
- Consignees were notified by letter (Urgent Product Recall) on 04/15/2008 and instructed to quarantine all affected kits for return to Merit. A Product Retrieval Form was included to be completed by the site representative. Please contact Greg Turner at 1-801-316-4998 or Jon Davis at 801-208-4497.
- Quantity
- 10 kits
- Distribution
- MO. Foreign distribution to Japan. No military or government distribution.
- Lot, serial or model codes
- Lot Number F603790
- 510(k) numbers
- not on file
- 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