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Z-0744-2016 Class II Terminated

Recalled by Acist Medical Systems — Eden Prairie, MN

FDA device recall Z-0744-2016 was initiated by Acist Medical Systems on December 21, 2015 and is designated Class II. Reason for recall: Reports related to ingress of air into the manifold. The recall status is terminated (terminated July 22, 2016). Affected quantity: 48,614 cartons or 486,140 units.

Recall Details

Product Type: Devices
Report Date: February 10, 2016
Initiation Date: December 21, 2015
Termination Date: July 22, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48,614 cartons or 486,140 units

Product Description

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

Reason for Recall

Reports related to ingress of air into the manifold.

Distribution Pattern

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, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.

Code Information

Lot Number 08915J 09015T 09115H 09315D 09615N 09615U 09715X 09815F 10115D 10215G 10415D 10415W 10415Y 10515P 11015L 11115K 11215U 11315M 11715J 11815G 11915D 12415J 12615P 13115M 13415W 13815G 13915T 14015P 14115M 14615D 14615M 15415G 15715D 16115H 16315L 16515E 16615Z 16815J 16915N 17115F 17615U 17815F 18215J 18415D 18515N 18715U 18815K 18915P 19015N 19115H 19315D 19415P 19515X 19715G 19815M 19915D 20115M 20315E 20715D 20815M 20915X 21115W 21815J 21815U 22015D 23715D 23815D 23815P 24415P 24615U 25015D 25515D 26415N 26715F 26815J 26815K 27115L 27215U 27315Z 27415H 27515D 29115D 29915E 29915F 30015E 30015F 32115M 32715G 32715V 32815M