Z-1002-04

AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System

Name: Z-1002-04 AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System
Creator: Acist Medical Systems
Published: 2004-05-19
License: https://open.fda.gov/license/

Acist Medical Systems, Inc. / initiated 2004-05-19 / Terminated / root cause: packaging

FDA source

Acist Medical Systems began a recall of AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System on 2004-05-19. The reason FDA records is "Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1002-04
Status: Terminated
Initiated: 2004-05-19
Posted: 2004-07-20
Terminated: 2005-11-03
Recalling firm: Acist Medical Systems, Inc.
Product: AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
Root cause tag: packaging
FDA root cause: Other
Action: Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.
Quantity in commerce: 3590 kits
Product codes and lots: Lot # 0584B

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)