Reported Apr 24, 2013 · Terminated
ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion…
Acist Medical Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acist Medical Systems · 7905 Fuller Rd · Eden Prairie, MN · 55344-2137
Is this the product you have?
- 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.
- Lot codes and dates
238840072388400823884009
- Amount recalled
- 6640 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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