FDA-Device2013-04-24Class II
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.
Acist Medical Systems
Hazard
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
Sold states
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.
Affected count
6640 units
Manufactured in
7905 Fuller Rd, N/A, Eden Prairie, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2013Don't want to check this manually?
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