| Class 2 Device Recall ACIST | |
Date Initiated by Firm | March 15, 2013 |
Date Posted | April 18, 2013 |
Recall Status1 |
Terminated 3 on August 07, 2013 |
Recall Number | Z-1145-2013 |
Recall Event ID |
64840 |
510(K)Number | K040298 |
Product Classification |
Injector and syringe, angiographic - Product Code DXT
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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 MN 55344-2137
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For Additional Information Contact | 952-941-9300 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = DXT
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