Reported Feb 10, 2016 · Terminated
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits,…
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, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
- Lot codes and dates
- Lot Number
90 of 90 codes
08915J09015T09115H09315D09615N09615U09715X09815F10115D10215G10415D10415W10415Y10515P11015L11115K11215U11315M11715J11815G11915D12415J12615P13115M13415W13815G13915T14015P14115M14615D14615M15415G15715D16115H16315L16515E16615Z16815J16915N17115F17615U17815F18215J18415D18515N18715U18815K18915P19015N19115H19315D19415P19515X19715G19815M19915D20115M20315E20715D20815M
- Lot Number
- Amount recalled
- 48,614 cartons or 486,140 units
Where it was sold
Why it was recalled
Reports related to ingress of air into the manifold.
This product could cause temporary or reversible health problems — stop using it.
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