Infusor, Pressure, For I.V. Bags
FDA adverse event reports and recall history for infusor, pressure, for i.v. bags (product code KZD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 508
- Deaths
- 15
- Injuries
- 42
- Malfunctions
- 432
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-06-24TerminatedDevice Design
Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.
Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.
- 2009-12-14TerminatedOther
Merit Medical Sysems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag CATALOG NUMBER PIB500 Used to apply pressure to a sealed bag of sterile fluid.
Potential sterility breach caused by excessive shipment damage.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model: 803FGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve. Model : A903SGA. The letter A refers to a special quantity designator for a particular customer. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor Classic with piston gauge and stopcock valve Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- 2008-12-29TerminatedEquipment maintenance
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
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