REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Recall
- Recall Number
- Z-0746-2021
- Event Number
- 86903
- Firm
- Westmed, Inc.
- FEI Number
- 1000374126
- Product Code
- KGB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 11, 2020
- Terminated
- February 7, 2023
- Address
- 5580 S Nogales Hwy, Ste 170, Tucson, AZ, 85706-3333
Description
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
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.
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.
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
6000 units