Recall Z-2253-2015— Oxysure Systems, Inc.

Name: FDA recall Z-2253-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-12

Class II · Terminated

Class II FDA medical device recall by Oxysure Systems, Inc., initiated 2015-06-12, terminated 2020-10-19. It names one FDA 510(k) clearance: K052396. Product: OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.. Reason: 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..

Recalling firm: Oxysure Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-12
Terminated: 2020-10-19
Firm location: Frisco, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K052396 — OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615Oxysure Systems, Inc.·cleared 2005-12-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.