Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.

FDA Recall Z-0257-05 · Posted 2004-11-24

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2004-11-03
Date Terminated2005-04-20
Product Quantity875, 798 kits

Reason for Recall

Sterility can be compromised by a tear in the outer packaging.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023183MEDRAD STELLANT CT INJECTOR SYSTEMMedrad, Inc. · 2003-01-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑