Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
This recall has been terminated (originally issued November 24, 2004).
- Company
- Medrad Inc
- Recall Initiated
- November 3, 2004
- Posted
- November 24, 2004
- Terminated
- April 20, 2005
- Recall Number
- Z-0257-05
- Quantity
- 875, 798 kits
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility can be compromised by a tear in the outer packaging.
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 / Code Info
Lot Numbers 38821 through 45666 for each catalog number, Expiration Date October 2008.
Root Cause
Other
Action Taken
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.