Class 2 Device Recall ACIST

• Date Initiated by Firm: October 02, 2003
• Date Posted: October 24, 2003
• Recall Status: Terminated on November 23, 2005
• Recall Number: Z-0064-04
• Recall Event ID: 27388
• 510(K)Number: K984231 K991103
• Product Classification: Injector And Syringe, Angiographic - Product Code DXT
• Product: ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
• Code Information: Lot Numbers 0933A and 1003I
• Recalling Firm/ Manufacturer: Acist Medical Systems; 7450 Flying Cloud Dr.; Suite 150; Eden Prairie MN 55344
• For Additional Information Contact: Carl Beaurline; 952-941-3507
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXT; 510(K)s with Product Code = DXT