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A product malfunction could cause potential over-infusion or unintended delivery of medication.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
The Class I recall involves complaints that the connector disconnects from the breathing unit.
Medtech manufacturers must continue to embrace collaboration and transparency.
The use of such devices could result in patient injury or even death.
Risks related to balloon deflation, fragmentation and detachment could lead to serious adverse events, including death.
Infusion pump companies are perpetuating misconceptions.
The agency issued a letter to healthcare providers following a journal study about the potential risk of these devices in patients with a type of peripheral arterial disease.