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Terminated

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

FDA Recall Z-0064-04 · Posted 2003-10-24

Recalling FirmAcist Medical Systems
Recall StatusTerminated
Product CodeDXT
Date Initiated2003-10-02
Date Terminated2005-11-23
Product Quantity7120 kits

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

Nationwide in the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART BInvasatec · 2000-05-31K991103MODIFICATION TO ACIST CL 100HAcist Medical Systems · 2000-05-31

Official Source

View FDA Recall →

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

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