Home / Recalls / Oxysure Systems, Inc. / Z-2253-2015

Z-2253-2015 Class II Terminated

Recalled by Oxysure Systems, Inc. — Frisco, TX

Recall Details

Product Type
Devices
Report Date
August 5, 2015
Initiation Date
June 12, 2015
Termination Date
October 19, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1005 units

Product Description

OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

Reason for Recall

Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.

Distribution Pattern

Nationwide throughout the US and Chile, Trinidad, China

Code Information

lots 61-65