Covidien, LP recalls Electrostatic Filter Angled, Item Code 350S19006 - Product U
Recalled Product
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
Hazard / Issue
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Issued by
FDA
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