FDA Device recall Z-1145-2013
ACIST Medical Systems Inc
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of ACIST Medical Systems Inc by Acist Medical Systems, citing 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 rel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-15 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acist Medical Systems |
| Distribution | US |
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.
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
Identifiers
| code_info | 23884007, 23884008, 23884009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2013%22
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