Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2253-2015 — OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.

U.S. FDA — Device Enforcement · United States · 2015-06-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2253-2015
Date of alert
2015-06-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Oxysure Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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