FDA Medical Device Recalls (openFDA)
Medrad Inc: Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
- Recall number
- Z-0039-05
- Recalling firm
- Medrad Inc
- Product
- Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
- Status
- Terminated
- Initiated
- 2004-10-08
- Posted
- 2004-10-22
- Terminated
- 2005-01-25
- Reason
- Sterility can be compromised by a component tearing the outer packaging
- Root cause
- Other
- Action
- The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.
- Quantity
- 1650 kits
- Distribution
- The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.
- Lot, serial or model codes
- Lot number 45535 exp 9/2008
- 510(k) numbers
- ["K023183"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 2520313
- Firm city
- Indianola
- Firm state
- PA
- 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