All recalls8,436 total
potential Listeria Monocytogenes Contamination
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Inconsistent size terminology and color coding used on labeling
Inconsistent size terminology and color coding used on labeling
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Product is Stevia powder but bottle was mis-labeled as Pure Monk Fruit Sweetener.
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Inaccurate temperature reading from a thermometer on one pasteurization machine
Salmonella. The firm was notified by the FDA that the product may be contaminated with Salmonella.
Temperature abuse due to temperature excursion in one shipping trailer
Product is Monk Fruit powder but bottle was mis-labeled as Organic Pure Stevia.
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
allergen labeling - undeclared milk
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
Temperature abuse due to temperature excursion in one shipping trailer
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
The products may contain surface and subsurface contamination of Listeria monocytogenes.