| Class 2 Device Recall Westmed Oxygen Delivery Mask with Tubing Kit | |
Date Initiated by Firm | November 11, 2020 |
Create Date | December 29, 2020 |
Recall Status1 |
Terminated 3 on February 07, 2023 |
Recall Number | Z-0741-2021 |
Recall Event ID |
86903 |
510(K)Number | K913164 |
Product Classification |
Mask, oxygen, non-rebreathing - Product Code KGB
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Product | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. |
Code Information |
Lot # 091120N53 |
Recalling Firm/ Manufacturer |
Westmed, Inc. 5580 S Nogales Hwy Ste 170 Tucson AZ 85706-3333
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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 | 3000 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KGB
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