FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc: Custom Angiographic Kit.
- Recall number
- Z-0620-03
- Recalling firm
- Merit Medical Systems, Inc
- Product
- Custom Angiographic Kit.
- Status
- Terminated
- Initiated
- 2003-02-13
- Posted
- 2003-03-06
- Terminated
- 2003-03-07
- Reason
- A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
- Root cause
- Other
- Action
- Consignees were notified by phone and FAX on 2/12/2003.
- Quantity
- 250 kits
- Distribution
- FL and Japan.
- Lot, serial or model codes
- Model Number: K04-00278/A. Lot Numbers: A253131.
- 510(k) numbers
- ["K883718","K913682","K934123","K973230"]
- 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