ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of
FDA device recall Z-1145-2013 · posted 2013-04-18 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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.
- Date initiated
- 2013-03-15
- Date posted
- 2013-04-18
- Date terminated
- 2013-08-07
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS (K040298) | Acist Medical Systems, Inc. | 2004-03-15 |