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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
Recall Number Z-1145-2013
Classification Class II
Code Info 23884007, 23884008, 23884009
Product Distributed Qty 6640 units
Reason For Recall ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor halting the injection, and normally replacement of the BT2000 Automated Manifold Kit is necessary in order to proceed with the injection. To date, there has been no evidence or report of any air injection to a patient, injury or adverse health consequence associated with this issue.

Event Detail

Event Id 64840
Product Type Devices
Status Ongoing
Recalling Firm Acist Medical Systems
City Eden Prairie
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.