Tag Archives: Class I recall
Medtronic Activa1

Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit Recalled (Class I) due to Potential for Damage

The FDA warns neurology, nursing, risk managers and surgery personnel that Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit are recalled due to potential for damage that may cause lead replacement. Background of Deep Brain Stimulation Lead Kit & Activa Dystonia HDE Kit Deep Brain Stimulation systems provide electrical stimulation to selected [...]

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Cardinal Health

Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit, by Cardinal Health, Recalled (Class I)

Anesthesiology, biomedical engineering, surgery personnel and risk managers are informed by the FDA that various presource kits containing pre-assembled anesthesia circuit, by Cardinal Health, are recalled because they main contain outer plastic packaging. Remnants of the plastic may cause serious adverse events including death. Background of Presource Kits Pre-Assembled Filter and Anesthesia Circuits, by Cardinal [...]

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GemStar Infusion System, by Hospira Inc., Recalled (Class I) due to Damage from Battery Leakage [update]

GemStar Infusion System, by Hospira Inc., Recalled (Class I) due to Damage from Battery Leakage [update]

[Update] The US FDA informs that GemStar Infusion System, by Hospira Inc., is recalled due to damage from battery leakage that may cause the device to shut off with no warning and may lead to serious injuries or death. Background of GemStar Infusion System The GemStar Infusion System, by Hospira Inc., is a small device [...]

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GemStar

GemStar Infusion System, by Hospira Inc., Recalled (Class I) due to Lithium Battery Low Voltage

The US FDA informs risk managers, biomedical engineering and nursing personnel that GemStar Infusion System, by Hospira Inc., is recalled due to lithium battery low voltage that could result in serious adverse events or death. Background of GemStar Infusion System The GemStar Infusion System, by Hospira Inc., is a small device used in intravenous, subcutaneous, [...]

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