Device product
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Z-1596-2015
Product summary
- Firm
- Arc Medical Inc
- Event
- Event 70662
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1810 units
- Official record key
device-enforcement:Z-1596-2015
Official wording
Reason: Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Code information: Product code: 6160, Batch number: 110208-50
Distribution pattern: Distributed in CA and NC.
Derived failure modes
-
Unknown
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.