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U.S. Department of Health and Human Services

Class 2 Device Recall ACIST Medical Systems Automated Manifold Kits

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  Class 2 Device Recall ACIST Medical Systems Automated Manifold Kits see related information
Date Initiated by Firm December 21, 2015
Date Posted February 02, 2016
Recall Status1 Terminated 3 on July 22, 2016
Recall Number Z-0744-2016
Recall Event ID 72913
510(K)Number K984231  K052744  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product 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
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                                                                                                                                                        
Recalling Firm/
Manufacturer		 Acist Medical Systems
7905 Fuller Rd
Eden Prairie MN 55344-2137
For Additional Information Contact ACIST Customer Service
888-670-7701
Manufacturer Reason
for Recall		 Reports related to ingress of air into the manifold.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Acist sent an Urgent Medical Device Recall letter dated December 21, 2015, via e-mail to all affected consignees. The letter was addressed to Distribution Partner or Cardiac Cath Lab / Material Manager in the USA. In Europe, the letter was addresses to Purchasing Department. The letter described the problem and the product involved in the recall. Advised consignees to return affected units and to complete and return the Medical Device Recall Form. Distributors were further advised to send the recall letter to their customers. For questions or concerns, contact in US, ACIST Customer Service 1-888-670-7701 or your ACIST Sales Representative. Europe Direct contact ACIST Europe Customer Service +44 (0) 845 548 12 80 or contact your ACIST Sales Representative, Europe Indirect contact ACIST Europe Customer Service +31 45 750 70 25 or contact your Distributor. Distributors contact: ACIST Europe BV, Office: +31 (0)45 750 7015, Mobile: +31 (0)6 233 648 46.
Quantity in Commerce 48,614 cartons or 486,140 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = ACIST MEDICAL SYSTEMS, INC.
510(K)s with Product Code = DXT and Original Applicant = INVASATEC
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