FDA-Device2015-05-20Class III
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Arc Medical Inc
Hazard
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Sold states
Distributed in CA and NC.
Affected count
1810 units
Manufactured in
4296 Cowan Rd, N/A, Tucker, GA, United States
Products
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1596-2015Don't want to check this manually?
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