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U.S. Department of Health and Human Services

Class 2 Device Recall ACIST

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 Class 2 Recall
ACIST
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on August 07, 2013
Recall Number Z-1145-2013
Recall Event ID 64840
Premarket Notification
510(K) Number
K040298 
Product Classification Injector And Syringe, Angiographic - Product Code DXT
Product 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.
Code Information 23884007, 23884008, 23884009
Recalling Firm/
Manufacturer
Acist Medical Systems
7905 Fuller Rd
Eden Prairie, Minnesota 55344-2137
Manufacturer 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
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action ACIST Medical Systems sent an Urgent Medical Device Recall letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter advised customers that if they had inventory of any of the lots under the scope of the recall, to discontinue use or further distribution of the product. If you possess inventory containing any of the lot numbers listed above, please discontinue use or further distribution of these products. Please return this inventory to ACIST. Upon receipt of the returned BT2000 Automated Manifold Kits, ACIST will arrange for a shipment of replacement kits at no charge. To order additional or immediate replacement product, please contact BRACCO customer service at 1-877-BRACCO9 (1-877-272-2269), option 1. Please also complete and return the enclosed Medical Device Recall Form (see enclosure). Even if you do not possess any of the affected product in your inventory, the form needs to be completed and returned, indicating that you have no remaining units containing these lot numbers in your inventory.
Quantity in Commerce 6640 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = ACIST MEDICAL SYSTEMS, INC.
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