Philips has issued updated use instructions for several ventilator models following an FDA Class I recall due to risks of aerosol deposits accumulating on internal flow sensors when in-line nebulizers are used.
Philips has issued updated use instructions for several ventilator models following an FDA Class I recall due to risks of aerosol deposits accumulating on internal flow sensors when in-line nebulizers are used.
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The FDA has issued a Class I recall for certain lots of Percussionaire’s Phasitron 5 breathing circuits.
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The FDA has updated its guidance on GE HealthCare’s EVair compressor, confirming that formaldehyde emissions are within safety limits, while previous recommendations remain in place for the EVair 03 (Jun-Air) compressor.
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Smiths Medical has issued guidance for customers on identifying and discarding affected products.
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Baxter Healthcare has issued a correction for the Life2000 ventilator due to a potential alarm failure, with a software update forthcoming to address the issue.
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Mercury Medical is recalling Neo-Tee Resuscitators due to a risk of the inline controller malfunctioning, potentially causing a loss of ventilation.
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The correction addresses potential risks of aerosol buildup on ventilator flow sensors when using in-line nebulizers.
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Sentec/Percussionaire has updated use instructions for Phasitron 5 In-Line Valve to prevent accidental misuse of expiratory port plug.
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Philips Respironics has issued a software update and revised user instructions for its Trilogy ventilators to address previously reported and new safety risks.
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Smiths Medical has issued a correction for paraPAC Plus P300 and P310 ventilators due to a faulty tidal volume knob that may cause unintended changes in ventilation.
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Gilead has recalled one lot of Veklury (remdesivir) after confirming the presence of a glass particle in a vial following a customer complaint.
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Smiths Medical has issued a recall of PneuPAC paraPAC Plus P300 and P310 ventilators due to a faulty patient outlet connector that can loosen or detach.
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The FDA says it has repeatedly called for a recall of SnoreStop Nasal Spray due to contamination risks, but the manufacturer has not complied to date.
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Smiths Medical is recalling certain tracheostomy tubes due to a defect that has been linked to two...
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An Urgent Medical Device Notification was issued for certain Bivona Tracheostomy Tubes due to a potential manufacturing defect that may cause the device to dislodge from its position in the trachea, according to an FDA alert.
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Internal testing identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time.
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The company is also updating use instructions for another video laryngoscope due to an increased risk of battery overheating and explosion.
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Baxter Healthcare Corp recalls certain Volara system single-patient use circuits and blue ventilator adapter assemblies due to disconnection risk that may prevent proper ventilation.
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Smiths Medical has alerted customers to a potential risk of tracheostomy tube displacement or decannulation due to a flange defect in certain Bivona tracheostomy tubes.
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Breas Medical has issued a nationwide correction for Vivo 45 LS ventilators due to potential short-term formaldehyde exposure.
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The recall affects specific lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to a potential disconnection issue that could disrupt ventilation.
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The correction addresses a software issue that can prevent the Hamilton-C6 ventilator from restarting after a sensor fail mode.
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Medtronic has recalled specific endotracheal tubes after receiving complaints about blockages leading to serious health risks, prompting an FDA alert to health care providers.
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The recall addresses a defect in the Inspire IV implantable pulse generator that may cause malfunctions and necessitate revision surgery for patients.
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