Recall Z-0744-2021— Westmed, Inc.
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 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - 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 recordK-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 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - 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.