Westmed, Inc. Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.