FDA Medical Device Recalls (openFDA)
Cardinal Health: Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
- Recall number
- Z-0266-04
- Recalling firm
- Cardinal Health
- Product
- Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA
- Status
- Terminated
- Initiated
- 2003-11-15
- Posted
- 2003-12-24
- Terminated
- 2005-10-20
- Reason
- The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
- Root cause
- Other
- Action
- Recalled by salesman visit on 11/15/03 and follow-up faxed letter dated 11/18/03. The hospital was instructed to inspect their inventory for the affected catalog number and work order numbers, segregating them and placing the provided warning labels on the pack. The warnijng labels instruct the user not to use the Namic Angiography Kit attached to the pack and return the kit to Cardinal Health.
- Quantity
- 1,083 kits
- Distribution
- Georgia, Alabama
- Lot, serial or model codes
- catalog number SAN25CCEAQ, lot numbers 548727, 548723, 544906, 542967, 542966
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAP
- Firm FEI
- 3001236905
- Firm city
- McGaw Park
- Firm state
- IL
- 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