Agency classClass IIOur severity:High FDA (Devices)·Z-0343-2020·Announced 2019-11-13

Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

Western / Scott Fetzer is recalling 486 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device intended for resuscitation and emergency oxygen delivery where a functional defect limits access to flow settings, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Western / Scott Fetzer Company is recalling 486 units of the Grab n Go Opti series VIPR system, Model # PRX-9653. The recall is due to a defect where the control knob may be rotated beyond its functional range, which results in limited access to flow settings.

The affected units were manufactured between August 31, 2014, and August 7, 2019. The devices are integrated delivery systems intended to provide supplemental oxygen to patients by prescription only. They are designed for emergency use by properly trained personnel for oxygen deficiency and resuscitation, as well as for limited duration use during patient transports.

Distribution was worldwide, including nationwide distribution in the United States across multiple states and in Costa Rica and Mexico. Consumers and healthcare facilities should contact Western / Scott Fetzer Company for instructions on how to address the defect.

The recalled product

Product: Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and…
Manufacturer: Western / Scott Fetzer Company
Category: Medical Device — Oxygen Delivery System
Hazard: functional-defect
inadequate-oxygen-delivery
Affected units: 486

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lot manufactured from 08/31/14 to 08/07/2019

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Western / Scott Fetzer Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Western / Scott Fetzer Company

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Same hazard · functional defect