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Terminated

Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

FDA Recall Z-0039-05 · Posted 2004-10-22

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2004-10-08
Date Terminated2005-01-25
Product Quantity1650 kits

Reason for Recall

Sterility can be compromised by a component tearing the outer packaging

Firm Action

The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.

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.

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