Recall Z-1145-2013 ยท DXT Injector And Syringe, Angiographic
Acist Medical Systems
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.
| Date | Apr 18, 2013 (initiated Mar 15, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 Auto |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS Acist Medical Systems, Inc., Mar 15, 2004 |