REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X ...
FDA Device Recall #Z-0743-2021 — Class II — November 11, 2020
Recall Summary
| Recall Number | Z-0743-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 11, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Westmed, Inc. |
| Location | Tucson, AZ |
| Product Type | Devices |
| 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
Lot / Code Information
Lot # 091620N04
Other Recalls from Westmed, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0263-2025 | Class II | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF... | Sep 27, 2024 |
| Z-0746-2021 | Class II | REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50... | Nov 11, 2020 |
| Z-0745-2021 | Class II | REF 0562K (Adult Elongated O2/CO2 Mask - Produc... | Nov 11, 2020 |
| Z-0741-2021 | Class II | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen... | Nov 11, 2020 |
| Z-0744-2021 | Class II | REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ ... | Nov 11, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.