Reported Nov 13, 2019 · Terminated
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery…
Western / Scott Fetzer Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Western / Scott Fetzer Company · 875 Bassett Rd · Westlake, OH · 44145-1142
Is this the product you have?
- Grab n Go Opti series VIPR system Model #
- PRX-9646 - Product UsageThe 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 resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. 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. The device is intended for limited duration use, such as would be necessary during patient transports
- Lot codes and dates
- All Lot manufactured from 08/31/14 to 08/07/2019
- Amount recalled
- 25,840 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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