REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
This recall has been terminated (originally issued November 11, 2020).
- Company
- Westmed Inc
- Recall Initiated
- November 11, 2020
- Terminated
- February 7, 2023
- Recall Number
- Z-0743-2021
- Quantity
- 600 units
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot # 091620N04
Root Cause
Process control
Action Taken
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, kgalvez@westmedinc.com, (520) 294-7987, Ext 1232.