Western Grab n Go Opti VIPR System Recalled for Control Knob Defect
Western / Scott Fetzer Company is recalling 1,287 Grab n Go Opti VIPR oxygen delivery systems because the control knob may rotate beyond its functional range, limiting access to flow settings.
What this means for you
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 involves a medical device where a functional defect (limited access to flow settings) poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Western / Scott Fetzer Company is recalling 1,287 units of the Grab n Go Opti series VIPR system, Model # PRX-9615. The recall is due to a defect where the control knob may be rotated beyond its functional range, which limits access to flow settings.
The affected devices are integrated delivery systems intended to provide supplemental oxygen by prescription only. They are used for oxygen deficiency and resuscitation, and are intended for limited duration use such as patient transports. The recall covers all lots manufactured between August 31, 2014, and August 7, 2019.
Distribution was worldwide, including nationwide distribution in the United States and specific countries such as Costa Rica and Mexico. Users should contact the manufacturer for further instructions on how to address the defect.
The recalled product
- Product
- Grab n Go Opti series VIPR system Model # PRX-9615 - 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 resuscitati
- Manufacturer
- Western / Scott Fetzer Company
- Affected units
- 1,287
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
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.
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