Food, drugs, devices › Westmed, Inc.
Device recall: REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Pro
FDA enforcement event 86903 is a device recall by Westmed, Inc. of Tucson, AZ, initiated 11 Nov 2020 and classified Class II, with 6 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 7 Feb 2023. Initiation: voluntary: firm initiated. Westmed, Inc. has 4 enforcement events on this register, with a median of 6 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Westmed, Inc., Tucson, AZ.
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
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0741-2021 | 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. | 3000 units | Class II | Terminated | 6 Jan 2021 |
| Z-0742-2021 | Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. | 37,300 units | Class II | Terminated | 6 Jan 2021 |
| Z-0743-2021 | 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. | 600 units | Class II | Terminated | 6 Jan 2021 |
| Z-0744-2021 | 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. | 1200 units | Class II | Terminated | 6 Jan 2021 |
| Z-0745-2021 | REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. | 16,000 units | Class II | Terminated | 6 Jan 2021 |
| Z-0746-2021 | REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. | 6000 units | Class II | Terminated | 6 Jan 2021 |
Context
Other enforcement events for Westmed, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Sep 2024 | 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The West | Device | Class II | 1 |
| 15 Jan 2019 | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID conn | Device | Class II | 3 |
| 18 Jan 2011 | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced H | Device | Class II | 14 |
All 4 events for Westmed, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Feb 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.