Recall Z-1145-2013— Acist Medical Systems
Class II · Terminated
Class II FDA medical device recall by Acist Medical Systems, initiated 2013-03-15, terminated 2013-08-07. It names one FDA 510(k) clearance: K040298. 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.
- Recalling firm
- Acist Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-15
- Terminated
- 2013-08-07
- Firm location
- Eden Prairie, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.