Home / Recalls / Acist Medical Systems / Z-1145-2013

Z-1145-2013 Class II Terminated

Recalled by Acist Medical Systems — Eden Prairie, MN

Recall Details

Product Type: Devices
Report Date: April 24, 2013
Initiation Date: March 15, 2013
Termination Date: August 7, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6640 units

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.

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 w

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.

Code Information

23884007, 23884008, 23884009