Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
95,025 total recalls in our database
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
Philips North America
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Magellan Diagnostics
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
Philips North America
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Philips North America
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
Philips North America
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Bard Access Systems
Catheter kits contained the incorrect micro-introducers.
Edwards Lifesciences
There is a potential that the pressure tubing may detach from the blood sampling system
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.