ThermoFlo 1 HME recalled over sterility concerns
- Recall date
- February 19, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Arc Medical Inc recalls ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
- Recall number
- Z-1596-2015
- FDA classification
- Class III
- Brand / firm
- Arc Medical Inc
- Sold / distributed
- Distributed in CA and NC.
Why it was recalled
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
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