FDA recall Z-0744-2021

Product

REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

Reason for recall

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

Key facts

Status

Terminated

Initiation date

2020-11-11

Report date

2021-01-06

Termination date

2023-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tucson, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2021