Western Grab n Go Opti VIPR System Recalled for Control Knob Defect
Western / Scott Fetzer Company is recalling 6,790 Grab n Go Opti series VIPR 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 defect limits access to flow settings, posing 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 where injury has not yet been reported.
Plain-English summary
Western / Scott Fetzer Company is recalling 6,790 units of the Grab n Go Opti series VIPR system, Model # PRX-9632. 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 Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen by prescription only. It is used for oxygen deficiency and resuscitation, and is intended for limited duration use such as during patient transports. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T.
Distribution was worldwide, including US nationwide distributions in states such as OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, and IA, as well as in Costa Rica and Mexico. Users should contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- Grab n Go Opti series VIPR system Model # PRX-9632 - 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
- 6,790
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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