Class 2 Device Recall Digital VIPR System

• Date Initiated by Firm: October 16, 2021
• Create Date: November 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0270-2022
• Recall Event ID: 88877
• Product Classification: Regulator, pressure, gas cylinder - Product Code CAN
• Product: Western Oxytote DTE Digital VIPR System (with E-size cylinder); ; Model: MNDS-603
• Code Information: 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)
• Recalling Firm/ Manufacturer: Western/Scott Fetzer Company; 875 Bassett Rd; Westlake OH 44145-1142
• For Additional Information Contact: Kellie Wargo; 800-783-7890
• Manufacturer Reason for Recall: VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.