The Recall Desk

FDA (Devices) recall action 86903

Westmed, Inc. recalled 6 products on 2021-01-06

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2021-01-06
Critical
0
Units
64,100

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2021-01-06

    Westmed Elongated Oxygen Mask Recalled for Loose Tube Connection

    Westmed is recalling 3,000 units of the REF 3102-E Elongated Oxygen Mask because the tube connection may become loose, potentially delaying oxygen therapy.

    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.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2021-01-06

    Westmed Adult Elongated Oxygen Mask Recalled for Loose Fitment

    Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.

    Product
    REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2021-01-06

    Westmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment

    Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.

    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.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2021-01-06

    Westmed Adult Oxygen Mask Recall Due to Potential Loose Fitment

    Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.

    Product
    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.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2021-01-06

    Westmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment

    Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.

    Product
    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.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2021-01-06

    Westmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment

    Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.

    Product
    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.
    Category
    Distribution
    13 states