FDA-Device2021-06-23Class II
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.
Covidien, LP
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
Affected count
192000
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2021Don't want to check this manually?
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