Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted ...
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerabl...
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class IReported ongoing
Distribution: Nationwide distribution. International distribution to Canada, France, and Germany.
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Class IReported ongoing
Distribution: Nationwide distribution. International distribution to Canada, France, and Germany.
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Class IIReported ongoing
Distribution: Distribution was made nationwide. There was also government/military distribution. Foreign distribution was made to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapo...
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prev...
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Florida.
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service incons...
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Colorado.
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guar...
Class IIReported ongoing
Distribution: US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and U...
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guar...
Class IIReported ongoing
Distribution: US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and U...
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guar...
Class IIReported ongoing
Distribution: US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and U...
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guar...
Class IIReported ongoing
Distribution: US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and U...
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the p...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the p...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Ireland, United Kingdom, and Hong Kong.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped...
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting i...
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.
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Checking Baxter Healthcare Corporation
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