ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Recall Z-1596-2015 · Posted 2015-05-09
Recalling FirmArc Medical Inc
Recall StatusTerminated
Product CodeBYD
Date Initiated2015-02-19
Date Terminated2017-08-29
Product Quantity1810 units
Reason for Recall
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Firm Action
Consignees were contacted by telephone on 02/19/2015.
Root Cause
Process control
Distribution Pattern
Distributed in CA and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.