Acist Medical Systems: Medical Device Recall in 2013 - (Recall #: Z-1145-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 15, 2013

Date Posted: April 24, 2013

Recall Number: Z-1145-2013

Event ID: 64840

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

Status: Terminated

Product Quantity: 6640 units

Code Information:

23884007, 23884008, 23884009

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.

Voluntary or Mandated:

Voluntary: Firm initiated