Recall Z-0741-2021— Westmed, Inc.

Name: FDA recall Z-0741-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-11

Class II · Terminated

Class II FDA medical device recall by Westmed, Inc., initiated 2020-11-11, terminated 2023-02-07. It names one FDA 510(k) clearance: K913164. 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.. Reason: 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..

Recalling firm: Westmed, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Terminated: 2023-02-07
Firm location: Tucson, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K913164 — NON REBREATHING MASKSpecialty Packaging Producs, Inc.·cleared 1992-01-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.