Z-0744-2021Class II

REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen...

Name: Z-0744-2021 REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen...
Creator: Westmed, Inc.
Published: 2020-11-11
License: https://open.fda.gov/license/

Westmed Inc / initiated 2020-11-11 / Terminated / root cause: manufacturing process

FDA source

Westmed, Inc. began a recall of 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... on 2020-11-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0744-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Posted: 2020-12-29
Terminated: 2023-02-07
Recalling firm: Westmed Inc
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.
Product code: KGB Mask, Oxygen, Non-Rebreathing
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 11, 2020, West Med, Inc. issued a recall notification for oxygen delivery products via E-Mail to affected consignees. In addition to informing consignees about the recall products, the firm asked consignees to take the following actions: 1. Please complete the attached response form and quarantine affected product. 2. DO NOT DESTROY OR DISPOSE OF PRODUCT AT THIS TIME. 3. Contact Kalyn Galvez-Latneau, Westmed Customer Service Manager, for additional information and to obtain a Return Material Authorization (RMA). Kalyn Galvez-Latneau, [email protected], (520) 294-7987, Ext 1232.
Quantity in commerce: 1200 units
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
Product codes and lots: Lot # 091720N71 (Distributed outside US)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0744-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0741-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0742-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0743-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0744-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0745-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0746-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-29

Product code KGB

K913164Class INon Rebreathing MaskSpecialty Packaging Producs, Inc. / cleared 1992-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)