Class II — Acist Medical Systems
| Recalling firm | ACIST MEDICAL SYSTEMS, INC. |
|---|---|
| Registered facility | ACIST MEDICAL SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| 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 |
| 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. |
| 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. |
| Initiated | 2013-03-15 |
| Classified | 2013-04-18 |
| Terminated | 2013-08-07 |
| Recall number | Z-1145-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Acist Medical Systems (Z-1145-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64840/
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