Z-0269-2022Class II

Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602

Name: Z-0269-2022 Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Creator: Western/Scott Fetzer Company
Published: 2021-10-16
License: https://open.fda.gov/license/

Western Enterprises, Inc. / initiated 2021-10-16 / Open, Classified / root cause: design

FDA source

Western/Scott Fetzer Company began a recall of Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602 on 2021-10-16. FDA classified it as Class II and gives the reason as "VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0269-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-16
Posted: 2021-11-19
Recalling firm: Western Enterprises, Inc.
Product: Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Product code: CAN Regulator, Pressure, Gas Cylinder
Reason for recall: VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
Root cause tag: design
FDA root cause: Device Design
Action: Western / Scott Fetzer Co. issued Urgent Medical device Recall letter, dated 10/15/21 distributed via USPS to consignees on 10/16/21, and emailed to the same consignees on 10/18/21. Letter states reason for recall , health risk and action to take: Fill facility employees are asked to verify the functionality of each unit through the observation of information on the digital display. Note that this direction and expectation is already clearly indicated in the product Operating Instructions and Inspection Guidelines. If the digital display shows the expected information as depicted in the Operating Instructions and Inspection Guidelines, the unit is functioning properly and may remain in use. If the digital display is blank, the unit is to be isolated and returned to Western for inspection. As a longer term solution, beginning in October 2021, product within the scope of the recall is to be corrected as follows: 1. For Digital VIPR products that do not include a cylinder (MNDR-600), units will be returned to Western via RGA to perform the following services: " Remove shroud from unit to determine battery type used " If 3500mAh battery found, replace it with 4000mAh battery " If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found " Remove potential burr / sharp edge from screw boss on regulator body " Replace back shroud with modified back shroud (pinch points removed) " Reassemble unit per revised assembly procedure " Apply new control knob sticker (green logo, silver background) Page 3 of 6 2. For Digital products that include a cylinder (ROC-9840 and MNDS-602), Western employees will visit customer fill facility locations to perform the following services: " Remove shroud from unit to determine battery type used " If 3500mAh battery found, replace it with 4000mAh battery " If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found " Remove potential burr / sharp edge from screw boss on regulator body " Re
Quantity in commerce: 40 units
Distribution: CT, MD, MT, OH
Product codes and lots: Units distributed from 05/29/20 to 08/31/21. Digital VIPR units manufactured and distributed after 08/31/21 are outside the scope of this recall and will be recognized by a green and silver control knob sticker (green logo, silver background)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0267-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-19
Z-0268-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-19
Z-0269-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-19
Z-0270-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-19

Product code CAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)