FDA Medical Device Recalls (openFDA)
Medrad Inc: Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
- Recall number
- Z-0257-05
- Recalling firm
- Medrad Inc
- Product
- Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
- Status
- Terminated
- Initiated
- 2004-11-03
- Posted
- 2004-11-24
- Terminated
- 2005-04-20
- Reason
- Sterility can be compromised by a tear in the outer packaging.
- Root cause
- Other
- Action
- The recalling firm issued recall letters dated 11/1/04 to their consignees informing them of the problem and the need to return the product.
- Quantity
- 875, 798 kits
- Distribution
- The product was shipped to distributors and medical facilities nationwide. The product was also shipped to Saudia Arabia, Kuwaitt, Maylasia, Israel, Chile, Hong Kong, Great Britain, Denmark, Germany, China, Canada, France, Taiwan, Thailand, Singapore, Finland, Phillipines, Norway, Netherlands,, Spain, Mexico, Czech, Japan, Italy, Sweden, Brazil, Belgium, and Austraila.
- Lot, serial or model codes
- Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 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