Acist Medical Systems recalls ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Ste…

Recall date

December 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0744-2016

FDA classification

Class II

Brand / firm

Acist Medical Systems

Sold / distributed

Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Gr…

Why it was recalled

Reports related to ingress of air into the manifold.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures