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

Recall Z-1288-2018 — Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.

U.S. FDA — Device Enforcement · Canada · 2017-10-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1288-2018
Date of alert
2017-10-17
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
Southmedic, Inc.
Product category
device
Product type
Devices
Reported risk: Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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