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U.S. Department of Health and Human Services

Class 2 Device Recall Westmed Oxygen Delivery Mask with Tubing Kit

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  Class 2 Device Recall Westmed Oxygen Delivery Mask with Tubing Kit see related information
Date Initiated by Firm November 11, 2020
Create Date December 29, 2020
Recall Status1 Terminated 3 on February 07, 2023
Recall Number Z-0745-2021
Recall Event ID 86903
510(K)Number K913164  
Product Classification Mask, oxygen, non-rebreathing - Product Code KGB
Product REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Code Information Lot # 081920N38 (Distributed outside US)
Recalling Firm/
Manufacturer		 Westmed, Inc.
5580 S Nogales Hwy Ste 170
Tucson AZ 85706-3333
For Additional Information Contact Sarder Mostofa
520-294-7987 Ext. 1244
Manufacturer 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.
FDA Determined
Cause 2		 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, kgalvez@westmedinc.com, (520) 294-7987, Ext 1232.
Quantity in Commerce 16,000 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KGB and Original Applicant = SPECIALTY PACKAGING PRODUCS, INC.
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