Z-0743-2021 Class II Terminated
FDA device recall Z-0743-2021 was initiated by Westmed, Inc. on November 11, 2020 and is designated Class II. 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 … The recall status is terminated (terminated February 7, 2023). Affected quantity: 600 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 11, 2020
- Termination Date
- February 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 units
Product Description
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - 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.
Distribution Pattern
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
Code Information
Lot # 091620N04