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Terminated

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

FDA Recall Z-2253-2015 · Posted 2015-07-24

Recalling FirmOxysure Systems, Inc.
Recall StatusTerminated
Product CodeCAW
Date Initiated2015-06-12
Date Terminated2020-10-19
Product Quantity1005 units

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.

Firm Action

The recalling firm will notify their affected customers via email beginning the week of 6/15/15. The recall notification will have a response for to be completed by the consignee. The recall notification calls for the customers to dispose of the affected product according to the MSDS.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide throughout the US and Chile, Trinidad, China

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052396OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615Oxysure Systems, Inc. · 2005-12-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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