FDA Device

ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)

Hazard

Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.

What You Should Do

Remedy

The consignees were sent letters dated 10/2/03 which requested that the product be returned.

Products

ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
Brand
Acist Medical Systems
UPC
Lot Numbers 0933A and 1003I

Units Affected

7120 kits