Z-0064-04

ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management...

Name: Z-0064-04 ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management...
Creator: Acist Medical Systems
Published: 2003-10-02
License: https://open.fda.gov/license/

Acist Medical Systems, Inc. / initiated 2003-10-02 / Terminated

FDA source

Acist Medical Systems began a recall of ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) on 2003-10-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0064-04
Status: Terminated
Initiated: 2003-10-02
Posted: 2003-10-24
Terminated: 2005-11-23
Recalling firm: Acist Medical Systems, Inc.
Product: ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: 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.
FDA root cause: Other
Action: The consignees were sent letters dated 10/2/03 which requested that the product be returned.
Quantity in commerce: 7120 kits
Distribution: Nationwide in the United States.
Product codes and lots: Lot Numbers 0933A and 1003I

Product code DXT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)