Z-1596-2015 Class III Terminated
FDA device recall Z-1596-2015 was initiated by Arc Medical Inc on February 19, 2015 and is designated Class III. Reason for recall: Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. The recall status is terminated (terminated August 29, 2017). Affected quantity: 1810 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- February 19, 2015
- Termination Date
- August 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1810 units
Product Description
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
Reason for Recall
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Distribution Pattern
Distributed in CA and NC.
Code Information
Product code: 6160, Batch number: 110208-50